Protein supplementation in Hyperkalemia - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Hyperkalemia

Intervention / Treatment

Behavioral: Protein supplementation

Detailed Description

Randomized double blind prospective clinical trial. All infants admitted to University Hospital neonatal intensive care unit with birth weight of < 1000 grams, mmore than 24 weeks gestation and with no congenital anomalies will be enrolled in the study. This will include inborn infants and those that are transported from outlying hospitals and admitted at <12 hours of life. After informed consent, infants will be randomized to receive either standard of care nutritional management or nutritional management per study protocol with the addition of protein supplementation. Randomization will take place in the pharmacy.

Control Group: Infants enrolled in the control group will be started on intravenous fluids (IVF) on admission to the NICU with 5% Dextrose and 1500 mg calcium gluconate per 500 cc for a total fluid intake of either 120 or 150 cc/kg/day. The attending neonatologist in accordance with the infant's gestational age and maturity will make the decision regarding total fluid intake. The control group will be started at 0.5 gram/kg/d of protein ( Amynosin PF) on DOL 1 and increase by 0.5 gram/kg/day every day to a maximum of 3 grams/kg/day.

Study group: The study group will receive the same total fluid intake (120 cc/kg/day or 150 cc/kg/day) and 5% dextrose infusion with calcium gluconate and the addition of 2 grams/kg/day of protein (Aminosyn PF). The study group will receive 2 grams/kg/day of protein for 24 hours to 36 hours and will increase by 1 gram/kg/day up to a maximum of 4 grams/kg/day.

In both groups, caloric intake will start at 29-34 kcal/kg day (i.e., approximately 20-25 calories per kilogram from glucose and 9 calories per kilogram from lipids). Caloric intake will be progressively increased depending on the infant's tolerance to glucose. Protein to glucose ratio in the control group will be 250-312 and nitrogen balance ratio (including all calories) will be approximately 362-425. In the study group, protein to glucose ratio will be 64-80 and nitrogen balance ratio (including all calories) will be 93-109. The control group corresponds to the current standard of care. The study group nitrogen balance is within the limits of recent studies which show that a nitrogen balance ratio of 46-78 is appropriate for ELBW infants.

Glucose infusion rate (GIR) will be increased by attending neonatologist depending on infant's glucose tolerance. Usually GIR is started at 6 mg/kg/min and increased by 1 milligram per kilo per minute every 24 hrs. in ELBW infants. For fluctuations in glucose, adjustments in glucose infusion rate (GIR) will be via piggyback dextrose to the IVF if necessary.

Lipids will be supplied as a 20% solution and will be started by attending neonatologist according to standard of care (0.5-1 gr/kg first day of life, then increases of 0.5-1 gr/kg per day up to a maximum of 3 gr/kg day).

All infants will be started on Total Parenteral Nutrition (TPN) on DOL 1. The amino acid solution (Aminosyn PF) will be supplemented with 40 mg cysteine hydrochloride/kg/day in both groups since it is considered to be one of the essential amino acids for premature infants. Stable isotope studies have suggested improved protein retention with cysteine supplementation. 3 The amino acid solution will be added via pharmacy per study protocol. Subjects will continue to receive supplementation for the first week of life.

Initiation of feedings, TPN, fluid, and electrolyte intake will be determined by the attending neonatologist.

If the infant develops hyperkalemia (>6.5 mmol/lt), treatment will be determined by attending neonatologist based on standard of care incluiding: an increase in intravenous fluid delivery, diuretic therapy (lasix), correction of acidosis, close monitoring of ionized and total calcium levels and correction with calcium gluconate if needed, glucose and insulin infusion , kayexalate, and if refractory, exchange transfusion might be considered.

Following completion of the study, we will continue to monitor standard laboratory data, including serum and urine electrolytes. We will also monitor growth until hospital discharge. Following discharge, infants will be followed in PREMIEre clinic for neurodevelopmental outcome with Bayley testing at 6, 12, and 18 months CGA. In addition to the primary outcome reduction in incidence of hyperkalemia, our secondary outcomes of interest include the incidence of hyperglycemia, the incidence of periventricular-intraventricular hemorrhage (PIVH), renal function, growth, and neurodevelopmental outcome at 18 months corrected gestational age.

Study Type

Interventional

Enrollment

62

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Texas
  - San Antonio, Texas, United States, 78229
    - University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 hours (Child)

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria: ELBW infants with birth weight <1000 grams . Enrollment within the first 12 hr of life.

Exclusion Criteria: major congenital anomalies; gestational age less than 24 weeks, infants not resuscitated, death.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of hyperkalemia in between groups

Secondary Outcome Measures

Outcome Measure
Incidence of hyperglycemia, post-natal growth, neurodevelopmental outcome at 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

Principal Investigator: Cynthia L Blanco, MD, University of Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

July 1, 2007

Study Registration Dates

First Submitted

February 8, 2006

First Submitted That Met QC Criteria