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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

Tracking Information
First Submitted Date  ICMJE March 16, 2011
First Posted Date  ICMJE March 18, 2011
Results First Submitted Date  ICMJE February 9, 2015
Results First Posted Date  ICMJE March 10, 2015
Last Update Posted Date February 20, 2019
Study Start Date  ICMJE March 2011
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 24 Hours of Life [ Time Frame: 24 hours of life ]
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
Percentage of subjects in each group who have achieved an optimal mean blood pressure value at 24 hours of life [ Time Frame: 24 hours of life ]
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2019)
  • Heart Rate Change From Baseline [ Time Frame: 96 hours or until hypotension completely resolved and medications stopped ]
    Heart rate change from baseline during study drug administration
  • Acid-base Status [ Time Frame: 96 hours or until hypotension resolved and medication completely stopped ]
  • Hyponatremia [ Time Frame: 96 hours or until medication completely stopped ]
  • Urine Output [ Time Frame: 96 hours or until hypotension resolved and medication completely stopped ]
  • Evidence of Ischemic Changes [ Time Frame: 96 hours or until medication completely stopped ]
    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.
  • Necrotizing Enterocolitis [ Time Frame: until hospital discharge, up to 12 weeks ]
  • Ventilator Days [ Time Frame: Until hospital discharge, up to 15 months ]
  • Presence of Patent Ductus Arteriosus (PDA) [ Time Frame: until hospital discharge, up to 12 weeks ]
  • Grade 3 Intraventricular Hemorrhage or Worse on Head Ultrasound [ Time Frame: Until hospital discharge, up to 15 months ]
  • Retinopathy of Prematurity Stage 3 or Higher [ Time Frame: Until hospital discharge, up to 15 months ]
    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.
  • Presence of Bronchopulmonary Dysplasia (BPD) [ Time Frame: 36 weeks postmenstrual age ]
    Infants were evaluated for oxygen need at 36 weeks postmenstrual age. If they required supplemental oxygen, they were diagnosed with BPD
  • All Cause Mortality [ Time Frame: admission to hospital discharge, up to 15 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2011)
  • Systolic and Diastolic Blood Pressure values and Heart Rate [ Time Frame: 96 hours or until hypotension completely resolved and medications stopped ]
  • Acid-base Status [ Time Frame: 96 hours or until hypotension resolved and medication completely stopped ]
  • Lactate, glucose, and sodium levels [ Time Frame: 96 hours or until medication completely stopped ]
  • Urine Output [ Time Frame: 96 hours or until hypotension resolved and medication completely stopped ]
  • Evidence of ischemic changes [ Time Frame: 96 hours or until medication completely stopped ]
  • Enteral nutrition tolerance and presence of gastrointestinal complications (NEC, perforation) [ Time Frame: Until hypotension resolved, medication stopped, and full feeds established ]
  • Severity of lung disease, time on ventilator, time on any respiratory support, number of surfactant doses needed, need for oxygen therapy [ Time Frame: Until hospital discharge ]
  • Presence of patent ductus arteriosus (PDA) and need for medical or surgical treatment [ Time Frame: 24 hours through first several months of life ]
  • Head ultrasound diagnoses [ Time Frame: First week of life through to hospital discharge ]
  • Retinopathy of prematurity and need for medical or surgical treatment [ Time Frame: One month of age to hospital discharge ]
  • Presence and severity of bronchopulmonary dysplasia [ Time Frame: 36 weeks postmenstrual age to beyond hospital discharge ]
  • Neurodevelopmental Outcomes [ Time Frame: hospital discharge to follow up at 18-24 months of age ]
  • All Cause Mortality [ Time Frame: admission to hospital discharge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Dopamine Versus Vasopressin for Treatment of Low Blood Pressure in Low Birth Weight Infants
Official Title  ICMJE Dopamine Versus Vasopressin for Cardiovascular Support in Extremely Low Birth Weight Infants: A Randomized, Blinded Pilot Study
Brief Summary

Low blood pressure or hypotension is a very important problem that is often seen in premature babies, especially those with low birth weight. Severe hypotension leads to significant problems including brain bleeds, developmental delays, kidney and liver problems, and other issues that can affect babies for the rest of their lives. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Research is being conducted to try to find the best medication to use in these situations. Dopamine is often used first, but it does not always prove to be effective, and it has several concerning side effects. This study will look at vasopressin, which has fewer side effects, as a first-line medication for low blood pressure in extremely low birth weight infants.

Hypotheses and Specific Aims: This study will show superiority of vasopressin to dopamine in preterm, extremely low birth weight infants who have hypotension within the first 24 hours of life. We will specifically look at its ability to raise blood pressure values, improve clinical symptoms seen, any adverse effects, and clinical outcomes of babies being treated.

Detailed Description Hypotension in the low birth weight (LBW) and extremely low birth weight (ELBW) infant is often encountered in the postnatal adaptation phase. Severe, prolonged hypotension contributes to cellular dysfunction and cell death. Systemic hypotension affects close to half of all ELBW infants and a significant portion of LBW infants. The true definition of hypotension remains to be a question. There is a linear association between birth weight, gestational age, and mean blood pressure but blood pressure can vary significantly in the first day of life. The critical period tends to be the first 24-36 hours of life as blood pressure tends to rise significantly in the first 72 hours of life regardless of gestational age. Preterm infants suffering from hypotension have a higher incidence and increased severity of intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), and long-term neurodevelopmental sequelae compared to normotensive preterm infants. Effects on other organ systems can result in renal injury, hepatic injury, and the development of necrotizing enterocolitis among other complications. An important aspect in the management of infants with hypotension is the decision of when to treat and with what agent. Dopamine is commonly used as first-line therapy, but issues with efficacy and its side effect profile have lessened its favorability over the years. Few studies compare dopamine to other agents as a first -line treatment. This study hopes to contribute to the literature information on vasopressin as a potential first-line agent for treatment of neonatal hypotension in low birth weight infants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypotension
Intervention  ICMJE
  • Drug: 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
    Other Name: Dopamine Hydrochloride
  • Drug: 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
    Other Names:
    • Vasopressin
    • Antidiuretic Hormone (ADH)
    • Pitressin (US brand name)
    • Pressyn;Pressyn AR (Canadian brand names)
    • Argipressin
Study Arms  ICMJE
  • Active Comparator: Dopamine treatment
    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
    Intervention: Drug: Dopamine
  • Active Comparator: Vasopressin treatment
    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
    Intervention: Drug: Arginine Vasopressin
  • No Intervention: Comparison Arm
    Infants who did not require vasopressor support for hypotension during the first 24 hours of life
Publications * Rios DR, Kaiser JR. Vasopressin versus dopamine for treatment of hypotension in extremely low birth weight infants: a randomized, blinded pilot study. J Pediatr. 2015 Apr;166(4):850-5. doi: 10.1016/j.jpeds.2014.12.027. Epub 2015 Jan 29. Erratum in: J Pediatr. 2015 Jul;167(1):215.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2013)
70
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2011)
72
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Infants less than 24 hours of age
  • Infants with birth weight of <1001 grams and/or gestational age of <29 weeks
  • Not initiated on any continuous pressor therapy prior to enrollment
  • Intravenous line in place
  • Outborn infants meeting eligibility criteria

Exclusion Criteria:

  • Infants not meeting eligibility criteria
  • Infants with life-threatening congenital defects
  • Infants with congenital hydrops
  • Infants with frank hypovolemia (perinatal history consistent with decreased circulating blood volume plus clinical signs of hypovolemia)
  • Infants with other unresolved causes of hypotension (air leaks, lung overdistention, or metabolic abnormalities).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 24 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01318278
Other Study ID Numbers  ICMJE H-27661
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Danielle Rios, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Thrasher Research Fund
Investigators  ICMJE
Principal Investigator: Danielle R Rios, M.D. Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP