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Trial record 37 of 242 for:    furosemide

Oral Metolazone and Intermittent Intravenous Furosemide Versus Continuous Infusion Furosemide in Acute Heart Failure

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ClinicalTrials.gov Identifier: NCT00904488
Recruitment Status : Terminated (Difficult recruitment)
First Posted : May 19, 2009
Results First Posted : February 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Collaborators:
University of Illinois at Chicago
Virginia Commonwealth University
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acute Decompensated Heart Failure
Interventions Drug: Addition of oral Metolazone
Drug: Furosemide dose escalation
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description Furosemide dose escalation given either as IV bolus (2-2.5 x current dose) or continuous infusion (2-2.5 x current dose administered over previous 24 hours) Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Period Title: Overall Study
Started 5 6
Completed 5 6
Not Completed 0 0
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic Total
Hide Arm/Group Description IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours) Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose) Total of all reporting groups
Overall Number of Baseline Participants 5 6 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 6 participants 11 participants
57.6  (16.0) 55.8  (16.2) 56.6  (15.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Female
3
  60.0%
2
  33.3%
5
  45.5%
Male
2
  40.0%
4
  66.7%
6
  54.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
3
  50.0%
5
  45.5%
White
2
  40.0%
3
  50.0%
5
  45.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  20.0%
0
   0.0%
1
   9.1%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 5 participants 6 participants 11 participants
5
 100.0%
6
 100.0%
11
 100.0%
Baseline Ejection Fraction (EF) (%)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Mild (55-60%)
2
  40.0%
1
  16.7%
3
  27.3%
Moderate (20-40%)
1
  20.0%
5
  83.3%
6
  54.5%
Severe (5-15%)
2
  40.0%
0
   0.0%
2
  18.2%
Chief Complaints  
Measure Type: Number
Unit of measure:  Participants
Shortness of Breath (SOB) Number Analyzed 5 participants 6 participants 11 participants
2 2 3
Weight Gain Number Analyzed 5 participants 6 participants 11 participants
0 1 1
Fluid Overload Number Analyzed 5 participants 6 participants 11 participants
1 2 2
Afib on Admission  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Present
0
   0.0%
0
   0.0%
0
   0.0%
Absent
3
  60.0%
5
  83.3%
8
  72.7%
Not reported
2
  40.0%
1
  16.7%
3
  27.3%
New York Heart Association (NYHA) Class on Admission   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 6 participants 11 participants
Class I
0
   0.0%
0
   0.0%
0
   0.0%
Class II
0
   0.0%
0
   0.0%
0
   0.0%
Class III
0
   0.0%
3
  50.0%
3
  27.3%
Class IV
1
  20.0%
1
  16.7%
2
  18.2%
Not Reported
4
  80.0%
2
  33.3%
6
  54.5%
[1]
Measure Description:

ClassI No limitation of physical activity. Best outcome.

ClassII Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea (shortness of breath).

ClassIII Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, or dyspnea.

ClassIV Unable to carry on any physical activity without discomfort. Symptoms of heart failure at rest. If any physical activity is undertaken, discomfort increases. Worst outcome

Comorbidities  
Measure Type: Number
Unit of measure:  Participants
Anemia Number Analyzed 5 participants 6 participants 11 participants
2 0 2
Coronary artery disease (CAD) Number Analyzed 5 participants 6 participants 11 participants
1 3 4
Chronic obstructive pulmonary disease (COPD) Number Analyzed 5 participants 6 participants 11 participants
0 2 2
Cerebrovascular accident (CVA) Number Analyzed 5 participants 6 participants 11 participants
1 2 3
Diabetes Number Analyzed 5 participants 6 participants 11 participants
4 3 7
Dyslipidemia Number Analyzed 5 participants 6 participants 11 participants
4 2 6
Gastroesophageal reflux disease (GERD) Number Analyzed 5 participants 6 participants 11 participants
1 0 1
Gout Number Analyzed 5 participants 6 participants 11 participants
1 1 2
Human immunodeficiency virus (HIV) Number Analyzed 5 participants 6 participants 11 participants
1 0 1
Myocardial infarction (MI) Number Analyzed 5 participants 6 participants 11 participants
1 1 2
Hypertension Number Analyzed 5 participants 6 participants 11 participants
4 4 8
Obesity Number Analyzed 5 participants 6 participants 11 participants
2 1 3
Obstructive Sleep Apnea Number Analyzed 5 participants 6 participants 11 participants
2 2 4
Medication  
Measure Type: Number
Unit of measure:  Participants
Beta Blocker Number Analyzed 5 participants 6 participants 11 participants
4 4 8
Angiotensin-converting-enzyme inhibitor Number Analyzed 5 participants 6 participants 11 participants
4 6 10
Angiotensin Receptor Blockers Number Analyzed 5 participants 6 participants 11 participants
0 0 0
Loop Diuretic Number Analyzed 5 participants 6 participants 11 participants
4 5 9
Aldosterone Antagonist Number Analyzed 5 participants 6 participants 11 participants
0 1 1
Digoxin Number Analyzed 5 participants 6 participants 11 participants
2 0 2
Calcium Channel Blocker Number Analyzed 5 participants 6 participants 11 participants
2 1 3
Isosorbide Dinitrate Number Analyzed 5 participants 6 participants 11 participants
1 1 2
Hydralazine Number Analyzed 5 participants 6 participants 11 participants
4 1 5
Statin Number Analyzed 5 participants 6 participants 11 participants
5 4 9
Anticoagulant Number Analyzed 5 participants 6 participants 11 participants
2 3 5
Aspirin Number Analyzed 5 participants 6 participants 11 participants
2 5 7
Potassium supplement Number Analyzed 5 participants 6 participants 11 participants
1 3 4
Brain Natriuretic Peptide (BNP) at admission   [1] 
Mean (Standard Deviation)
Unit of measure:  Pg/ml
Number Analyzed 4 participants 3 participants 7 participants
6800.75  (10330.95) 5401.33  (4183.06) 6201.00  (7313.54)
[1]
Measure Analysis Population Description: BNP was not measured on admission as part of routine clinical care in all subjects.
1.Primary Outcome
Title Daily Net Fluid Output on Day 2 (24-48 Hours After Randomization)
Hide Description Net fluid output = fluid output during 24-48 hours after randomization - fluid intake during 24-48 hours after randomization. A negative value means that daily fluid intake was less than the daily fluid output.
Time Frame 24-48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mL/day
-1454.60  (1339.53) -1322.83  (1738.30)
2.Secondary Outcome
Title Daily Net Fluid Output on Days 1, 3, and 4
Hide Description Daily net fluid output = daily fluid output - daily intake. A negative value means that daily fluid intake was less than the daily fluid output.
Time Frame 0-24, 48-72, 72-96 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
If diuretic therapy is changed to the oral route before a scheduled efficacy endpoint is to be measured (e.g.72 or 96 hour net output), then that endpoint will not be obtained.
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: ml/day
0-24 hr Number Analyzed 5 participants 6 participants
-2226.74  (2063.63) -3076.67  (1555.63)
48-72 hr Number Analyzed 4 participants 5 participants
-2108.00  (2187.05) -409.74  (1208.98)
72-96 hr Number Analyzed 3 participants 3 participants
-2433.33  (1374.38) -705.33  (157.39)
3.Secondary Outcome
Title Daily Urine Output (mL Urine Out Per mg Furosemide (IV Equivalent) Received)
Hide Description [Not Specified]
Time Frame 0-24, 24-48, 48-72, 72-96 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected at all time points for all subjects, and were only analyzed when available. Data not analyzed on days when diuretics were held or discontinued.
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: ml/mg furosemide received
0-24 hr Number Analyzed 5 participants 6 participants
29.35  (21.01) 17.35  (7.11)
24-48 hr Number Analyzed 2 participants 5 participants
8.28  (4.59) 21.88  (14.39)
48-72 hr Number Analyzed 4 participants 3 participants
25.84  (20.05) 25.52  (14.84)
72-96 hr Number Analyzed 2 participants 0 participants
43.94  (28.12)
4.Secondary Outcome
Title Daily Weight
Hide Description [Not Specified]
Time Frame Baseline (Dry), Baseline, 0-24, 24-48, 48-72, 72-96 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected for all subjects at all time points, and were only analyzed when available
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: Kg
Baseline (Dry) Number Analyzed 4 participants 5 participants
82.35  (40.87) 100.82  (49.35)
Baseline Number Analyzed 5 participants 6 participants
120.84  (75.25) 102.57  (33.57)
0-24 hr Number Analyzed 3 participants 6 participants
154.23  (103.30) 101.07  (32.88)
24-48 hr Number Analyzed 4 participants 6 participants
129.73  (91.46) 99.08  (32.93)
48-72 hr Number Analyzed 3 participants 5 participants
135.07  (101.31) 106.70  (52.18)
72-96 hr Number Analyzed 2 participants 3 participants
172.10  (107.71) 86.87  (48.17)
5.Secondary Outcome
Title Patient Global Assessment Scale
Hide Description

Scale range: 1-5 Which of the following best describes your overall health state today?

  1. = markedly worse
  2. = worse
  3. = neither better nor worse
  4. = better
  5. = markedly better
Time Frame Baseline, 24, 48, 72, 96 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected at all time points, and were only analyzed when available.
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 4 participants 3 participants
3.25  (1.67) 3.67  (2.23)
24 hr Number Analyzed 5 participants 4 participants
4.2  (0.45) 4.25  (2.23)
48 hr Number Analyzed 5 participants 5 participants
3.8  (1.1) 3.6  (1.67)
72 hr Number Analyzed 3 participants 4 participants
4.67  (2.59) 3.75  (1.97)
96 hr Number Analyzed 2 participants 3 participants
4  (2.19) 4  (2.19)
6.Secondary Outcome
Title Physician Global Assessment Scale
Hide Description

Scale range: 1-5 Which of the following best describes the patient’s overall health state today?

  1. = markedly worse
  2. = worse
  3. = neither better nor worse
  4. = better
  5. = markedly better
Time Frame Baseline, 24, 48, 72, 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Data were not collected at all time points, and were only analyzed when available.
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 3 participants 2 participants
2.67  (1.67) 2  (1.21)
24 hr Number Analyzed 4 participants 4 participants
4.25  (1.95) 4  (2.16)
48 hr Number Analyzed 4 participants 5 participants
4  (1.92) 4  (1.63)
72 hr Number Analyzed 2 participants 4 participants
4.5  (2.49) 3.75  (1.97)
96 hr Number Analyzed 2 participants 4 participants
4  (2.19) 3.67  (2.19)
7.Secondary Outcome
Title Need for Additional or Alternative Diuretic (Crossover) or Other Vasoactive Therapy (Study Failure)
Hide Description Patients will be considered a treatment failure if they require additional diuretic (including crossover to the alternative study arm) or require IV vasoactive drug therapy (e.g. vasodilators including nitroglycerin or inotropes) as deemed appropriate/necessary by their medical team.
Time Frame 0-96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Measure Type: Count of Participants
Unit of Measure: Participants
1
  20.0%
4
  66.7%
8.Secondary Outcome
Title Time to Return to Baseline Weight
Hide Description [Not Specified]
Time Frame 0-96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Weight was not collected in all subjects every day.
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 4 6
Mean (Standard Deviation)
Unit of Measure: Days
1.5  (1.1) 1.5  (0.84)
9.Secondary Outcome
Title Length of Hospitalization
Hide Description [Not Specified]
Time Frame Assessed till hospital discharge, an average of 1 week (longest 29 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Data not available in all subjects.
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: Days
4.75  (1.71) 11.25  (10.93)
10.Secondary Outcome
Title 30-day All-cause Mortality
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Rehospitalization at 30 Days
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
30-day follow up data (except for mortality) were not collected in 2 participants
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
1
  20.0%
12.Secondary Outcome
Title Unscheduled Heart Failure Visits to Emergency Department or Outpatient Clinic
Hide Description [Not Specified]
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
30-day follow up data (except for mortality) were not collected in 2 participants
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
1
  20.0%
13.Secondary Outcome
Title Blood Urea Nitrogen (BUN)
Hide Description [Not Specified]
Time Frame Baseline, 24, 48, 72, 96 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description:
IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours)
Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: mg/dL
Baseline 31.20  (11.05) 29.83  (16.82)
24 hr 28.00  (9.35) 27.67  (17.18)
48 hr 30.80  (11.45) 33.17  (16.92)
72 hr 29.00  (12.08) 42.00  (20.70)
96 hr 38.60  (19.63) 42.67  (20.63)
Time Frame Changes in labs and vitals were collected for 96 hours after randomization All-cause mortality were collected for 30 days after randomization
Adverse Event Reporting Description
  • Total number of times antihypertensive doses are held due to low blood pressure
  • Number of hypotensive episodes defined as systolic blood pressure below 85 mmHg or greater than 10 mmHg below baseline (whichever is greater)
  • Number of critically low potassium (< 3.5 mmol/L) and magnesium (< 1.6 mg/dL) concentrations while receiving study therapy
 
Arm/Group Title Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Hide Arm/Group Description IV furosemide dose escalation via either intravenous bolus (2-2.5 x current dose) or continuous infusion furosemide (Furosemide 2-2.5 x current dose administered over previous 24 hours) Addition of oral metolazone 5 mg daily to continued intravenous bolus furosemide (Furosemide continued at current dose)
All-Cause Mortality
Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/6 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Furosemide Dose Escalation IVB Loop and PO Thiazide Diuretic
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/5 (40.00%)      6/6 (100.00%)    
Cardiac disorders     
critically low potassium (< 3.5 mmol/L) while receiving study therapy   0/5 (0.00%)  0 1/6 (16.67%)  1
critically low magnesium (< 1.6 mg/dL) while receiving study therapy   0/5 (0.00%)  0 1/6 (16.67%)  1
Hypotension   2/5 (40.00%)  8 6/6 (100.00%)  32
Hypotension resulting in holding antihypertensive doses  [1]  0/5 (0.00%)  0 1/6 (16.67%)  8
Indicates events were collected by systematic assessment
[1]
Reported as number of subjects affected/total at risk. Count of occurrence is total number of doses of antihypertensives being held.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jo Ellen Rodgers
Organization: UNC Eshelman School of Pharmacy
Phone: (919) 962-2249
EMail: jerodgers@unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00904488     History of Changes
Other Study ID Numbers: 08-1292
First Submitted: May 17, 2009
First Posted: May 19, 2009
Results First Submitted: December 8, 2017
Results First Posted: February 13, 2018
Last Update Posted: March 13, 2018