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Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01318278
Recruitment Status : Completed
First Posted : March 18, 2011
Results First Posted : March 10, 2015
Last Update Posted : February 20, 2019
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Danielle Rios, Baylor College of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypotension
Interventions Drug: Dopamine
Drug: Arginine Vasopressin
Enrollment 70
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Period Title: Overall Study
Started 10 10 50
Completed 10 10 50
Not Completed 0 0 0
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm Total
Hide Arm/Group Description

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life Total of all reporting groups
Overall Number of Baseline Participants 10 10 50 70
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 10 participants 10 participants 50 participants 70 participants
25.1  (1) 25.7  (2) 25.6  (1) 25.6  (1.4)
[1]
Measure Description: Gestational age of subjects in weeks
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 50 participants 70 participants
Female
5
  50.0%
4
  40.0%
28
  56.0%
37
  52.9%
Male
5
  50.0%
6
  60.0%
22
  44.0%
33
  47.1%
1.Primary Outcome
Title Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life
Hide Description Optimal mean blood pressure (OMBP) will be defined as either a 10% increase in mean blood pressure value or a 2-3 mmHg rise in mean blood pressure value AND an improvement in tissue perfusion as demonstrated by a resolution in the specified clinical symptom (designated upon enrollment) within 4-6 hours of having reached OMBP
Time Frame 24 hours of life
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is only reportable in the two treatment groups as it evaluates the response to treatment of hypotension in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.
Arm/Group Title Dopamine Treatment Vasopressin Treatment
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
9 9
2.Secondary Outcome
Title Heart Rate Change From Baseline
Hide Description Heart rate change from baseline during study drug administration
Time Frame 96 hours or until hypotension completely resolved and medications stopped
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome is only reportable in the two treatment groups as it evaluates the change in heart rate in those who received study drug. The comparison group infants were not hypotensive within the 24 hours and did not receive study drug, therefore, they are omitted from this outcome measure.
Arm/Group Title Dopamine Treatment Vasopressin Treatment
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Overall Number of Participants Analyzed 10 10
Mean (Standard Deviation)
Unit of Measure: beats per minute
31  (19) 0  (10)
3.Secondary Outcome
Title Acid-base Status
Hide Description [Not Specified]
Time Frame 96 hours or until hypotension resolved and medication completely stopped
Hide Outcome Measure Data
Hide Analysis Population Description
Treatment groups during study drug administration. Comparison group during first 96 hours of life. For all- only arterial gases
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Group
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants not diagnosed with hypotension in first 24 hours
Overall Number of Participants Analyzed 10 10 50
Mean (Standard Deviation)
Unit of Measure: pH
7.18  (.07) 7.2  (.07) 7.25  (.09)
4.Secondary Outcome
Title Hyponatremia
Hide Description [Not Specified]
Time Frame 96 hours or until medication completely stopped
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Measure Type: Number
Unit of Measure: participants
3 3 11
5.Secondary Outcome
Title Urine Output
Hide Description [Not Specified]
Time Frame 96 hours or until hypotension resolved and medication completely stopped
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Mean (Standard Deviation)
Unit of Measure: ml/kg/hr
4.4  (1.4) 3.5  (1.4) 3.9  (1.4)
6.Secondary Outcome
Title Evidence of Ischemic Changes
Hide Description Physical examinations were done on at least a twice daily basis to evaluate for any ischemic lesions (especially on the limbs) of all subjects. The presence of any lesion considered to be due to ischemia would have been reported in this data.
Time Frame 96 hours or until medication completely stopped
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Measure Type: Number
Unit of Measure: participants
0 0 0
7.Secondary Outcome
Title Necrotizing Enterocolitis
Hide Description [Not Specified]
Time Frame until hospital discharge, up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Measure Type: Number
Unit of Measure: participants
0 1 2
8.Secondary Outcome
Title Ventilator Days
Hide Description [Not Specified]
Time Frame Until hospital discharge, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Median (Inter-Quartile Range)
Unit of Measure: days
52
(37 to 160)
45.5
(23.5 to 56)
17.5
(1 to 38)
9.Secondary Outcome
Title Presence of Patent Ductus Arteriosus (PDA)
Hide Description [Not Specified]
Time Frame until hospital discharge, up to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Measure Type: Number
Unit of Measure: participants
5 6 34
10.Secondary Outcome
Title Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound
Hide Description [Not Specified]
Time Frame Until hospital discharge, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Measure Type: Number
Unit of Measure: participants
3 3 6
11.Secondary Outcome
Title Retinopathy of Prematurity Stage 3 or Higher
Hide Description

All subjects were followed by an ophthalmologist with initial exam at 4-6 weeks of age. The Stages describe the ophthalmoscopic findings at the junction between the vascularized and avascular retina. Each subject is followed until cleared by ophthalmology. For this outcome measure, the most severe stage of disease was used in analysis.

Stage 1 is a faint demarcation line. Stage 2 is an elevated ridge. Stage 3 is extraretinal fibrovascular proliferation (neovascularization). Stage 4 is sub-total retinal detachment. Stage 5 is total retinal detachment. Stages 1 and 2 do not lead to blindness. However, they can progress to the more severe stages.

Time Frame Until hospital discharge, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Measure Type: Number
Unit of Measure: participants
3 2 4
12.Secondary Outcome
Title Presence of Bronchopulmonary Dysplasia (BPD)
Hide Description Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD
Time Frame 36 weeks postmenstrual age
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Measure Type: Number
Unit of Measure: participants
8 4 31
13.Secondary Outcome
Title All Cause Mortality
Hide Description [Not Specified]
Time Frame admission to hospital discharge, up to 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description:

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Overall Number of Participants Analyzed 10 10 50
Measure Type: Number
Unit of Measure: participants
2 4 10
Time Frame Participants were followed for the duration of hospital stay, up to 15 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dopamine Treatment Vasopressin Treatment Comparison Arm
Hide Arm/Group Description

Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min

Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy

Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr

Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy

Infants who did not require vasopressor support for hypotension during the first 24 hours of life
All-Cause Mortality
Dopamine Treatment Vasopressin Treatment Comparison Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/10 (20.00%)   4/10 (40.00%)   10/50 (20.00%) 
Hide Serious Adverse Events
Dopamine Treatment Vasopressin Treatment Comparison Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/10 (80.00%)   7/10 (70.00%)   22/50 (44.00%) 
Gastrointestinal disorders       
Necrotizing Enterocolitis   1/10 (10.00%)  0/10 (0.00%)  7/50 (14.00%) 
Bowel Perforation   3/10 (30.00%)  2/10 (20.00%)  4/50 (8.00%) 
Infections and infestations       
Sepsis   4/10 (40.00%)  5/10 (50.00%)  11/50 (22.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dopamine Treatment Vasopressin Treatment Comparison Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/10 (30.00%)   4/10 (40.00%)   11/50 (22.00%) 
Renal and urinary disorders       
Hyponatremia   3/10 (30.00%)  4/10 (40.00%)  11/50 (22.00%) 
Indicates events were collected by systematic assessment
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. Danielle R. Rios
Organization: Baylor College of Medicine
Phone: 832-826-1380
EMail: drrios@texaschildrens.org
Layout table for additonal information
Responsible Party: Danielle Rios, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01318278    
Other Study ID Numbers: H-27661
First Submitted: March 16, 2011
First Posted: March 18, 2011
Results First Submitted: February 9, 2015
Results First Posted: March 10, 2015
Last Update Posted: February 20, 2019