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Effect of Acetazolamide and Furosemide on Obesity-induced Glomerular Hyperfiltration

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ClinicalTrials.gov Identifier: NCT01146288
Recruitment Status : Completed
First Posted : June 17, 2010
Results First Posted : June 4, 2015
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):
boris zingerman, Rabin Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Obesity-induced Hyperfiltration
Interventions Drug: Furosemide first, then Acetazolamide
Drug: Acetazolamide first, then Furosemide
Enrollment 13
Recruitment Details Participants recruited between July 2010 and October 2012.
Pre-assignment Details 19 screened, 6 excluded (2 did not meet inclusion criteria, 2 refused participation, 2 unable to adequately collect urine).
Arm/Group Title Acetazolamide First, Then Furosemide Furosemide First , Than Acetazolamide
Hide Arm/Group Description Intravenous acetazolamide 5 mg/kg/5 min. in first intervention period and intravenous furosemide 2 mg/5min in second intervention period (after washout period). Intravenous furosemide 2 mg/5min in first intervention period and intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
Period Title: First Intervention(1 Day)
Started 7 6
Completed 7 5
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Period Title: Second Intervention (1 Day)
Started 7 5
Completed 7 5
Not Completed 0 0
Arm/Group Title Acetazolamide First, Then Furosemide Furosemide First, Then Acetazolamide Total
Hide Arm/Group Description intravenous acetazolamide 5 mg/kg/5 min. in first intervention period, intravenous furosemide 2 mg/5min in second intervention period (after washout period). intravenous furosemide 2 mg/5min. in first intervention period, intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period). Total of all reporting groups
Overall Number of Baseline Participants 7 5 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 5 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
 100.0%
5
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 5 participants 12 participants
37  (6.6) 36  (7.1) 36  (8)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
male Number Analyzed 7 participants 5 participants 12 participants
7 5 12
1.Primary Outcome
Title Change in GFR (ml/Min)
Hide Description [Not Specified]
Time Frame baseline and after diuretics administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetazolamide Furosemide
Hide Arm/Group Description:
intravenous acetazolamide 5 mg/kg/5 min.
intravenous furosemide 2 mg/5min.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: ml/min
GFR before acetazolamide/furosemide administration 151  (22) 152  (18)
GFR after acetazolamide/furosemide administration 120  (16) 150  (28)
2.Primary Outcome
Title Renal Vascular Resistance (mm Hg/[ml/Min])
Hide Description [Not Specified]
Time Frame baseline and after diuretics administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acetazolamide Furosemide
Hide Arm/Group Description:
intravenous acetazolamide 5 mg/kg/5 min.
intravenous furosemide 2 mg/5min.
Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: mm Hg/[ml/min]
before acetazolamide/furosemide administration 0.078  (1.017) 0.073  (0.010)
after acetazolamide/furosemide administration 0.088  (0.021) 0.080  (0.019)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Acetazolamide Furosemide P-aminohippuric Acid
Hide Arm/Group Description Intravenous acetazolamide 5 mg/kg/5 min. Intravenous furosemide 2 mg/5min Intravenous priming dose of p-aminohippuric acid (8 mg/kg) before diuretics administration
All-Cause Mortality
Acetazolamide Furosemide P-aminohippuric Acid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Acetazolamide Furosemide P-aminohippuric Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0      1/13 (7.69%)    
Skin and subcutaneous tissue disorders       
angioedema  [1]  0/0  0 0/0  0 1/13 (7.69%)  1
Indicates events were collected by systematic assessment
[1]
angioedema after p-aminohippuric acid administration, before diuretics administration
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Acetazolamide Furosemide P-aminohippuric Acid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/12 (25.00%)      0/12 (0.00%)      0/12 (0.00%)    
General disorders       
hand paresthesia  [1]  2/12 (16.67%)  2 0/12 (0.00%)  0 0/12 (0.00%)  0
lip parestesia  [2]  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
alteration of the sense of taste  [3]  1/12 (8.33%)  1 0/12 (0.00%)  0 0/12 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
hand paresthesia following acetazolamide administration
[2]
lip paresthesia following acetazolamide administration
[3]
alteration of the sense of taste after acetazolamide administration
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 Boris Zingerman
Organization: Rabin Medical Center
EMail: borisz@clalit.org.il
Layout table for additonal information
Responsible Party: boris zingerman, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT01146288     History of Changes
Other Study ID Numbers: ObesAceta 1
First Submitted: June 16, 2010
First Posted: June 17, 2010
Results First Submitted: November 20, 2014
Results First Posted: June 4, 2015
Last Update Posted: June 4, 2015