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

NCT01318278 | Completed Results DMC

• 1 other identifier: H-27661
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypotension

Keywords

Hypotension; Low blood pressure; Neonate; Dopamine; Vasopressin; Extremely Low Birth Weight Infant

Outcome Measures

Primary Outcomes (1)

• Number of Subjects in Each Group Who Have Achieved an Optimal Mean Blood Pressure Value at 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

  24 hours of life

Secondary Outcomes (12)

• Heart Rate Change From Baseline

  96 hours or until hypotension completely resolved and medications stopped

• Acid-base Status

  96 hours or until hypotension resolved and medication completely stopped

• Hyponatremia

  96 hours or until medication completely stopped

• Urine Output

  96 hours or until hypotension resolved and medication completely stopped

• Evidence of Ischemic Changes

  96 hours or until medication completely stopped

Study Arms (3)

Dopamine treatment

ACTIVE COMPARATOR

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

Drug: Dopamine

Vasopressin treatment

ACTIVE COMPARATOR

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

Drug: Arginine Vasopressin

Comparison Arm

NO INTERVENTION

Infants who did not require vasopressor support for hypotension during the first 24 hours of life

Interventions

Dopamine DRUG

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

Also known as: Dopamine Hydrochloride

Dopamine treatment

Arginine Vasopressin DRUG

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

Also known as: Vasopressin, Antidiuretic Hormone (ADH), Pitressin (US brand name), Pressyn;Pressyn AR (Canadian brand names), Argipressin

Vasopressin treatment

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Baylor College of Medicine: lead
• Thrasher Research Fund: collaborator

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 25641242 DERIVED

MeSH Terms

Conditions

Hypotension; Diabetes Insipidus

Interventions

Dopamine; Arginine Vasopressin; Vasopressins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Danielle R. Rios
• Organization: Baylor College of Medicine

drrios@texaschildrens.org

832-826-1380

Study Officials

• Danielle R Rios, M.D.

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 16, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: September 1, 2013
• Last Updated: February 20, 2019
• Results First Posted: March 10, 2015

Record last verified: 2019-01

Locations

US (1)