Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants

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Brief Title

Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants

Official Title

Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants

Brief Summary

      The investigators will conduct a prospective, blinded, randomized, placebo-controlled trial
      with a sample size of 20 patients in each of the two arms (fenoldopam vs placebo) based upon
      a difference in serum creatinine by one standard deviation. Fluid and salt intake will be
      held constant within clinical parameters and carefully measured. Fenoldopam will be started
      at 0.1 ug/kg/min. If, after 6 hrs there is no decrease in blood pressure, the dose will be
      increased to 0.2 ug/kg/min. This dose will be continued throughout the remainder of the
      study. A study of pediatric patients previously provided to the FDA showed no hypotension at
      a dose of 0.2 ug/kg/min. Fenoldopam will be started 12 hrs before the first dose of
      indomethacin and discontinued 12 hrs after the 3rd dose of indomethacin. Study samples will
      include both blood and urine. The primary outcome will be a reduction in renal dysfunction,
      as determined by creatinine and urine output over the course of treatment. Additional
      outcomes will include determination of known and novel metabolomic urine markers of renal
      dysfunction.

Detailed Description

      Hypotheses

        -  The investigators primary hypothesis is that fenoldopam reduces renal dysfunction
           associated with indomethacin administration for closure of patent ductus arteriosus in
           preterm infants. A secondary endpoint or measured outcome will be the determination of
           fenoldopam pharmacokinetics in the premature population. Lastly, the investigators
           hypothesize that urine and serum acute kidney injury (AKI) biomarkers will be superior
           to contemporary neonatal AKI definitions in their ability to identify renal injury.

      Specific Aims

        -  Evaluate the effect of fenoldopam on renal function in preterm infants administered
           indomethacin

        -  Determination of fenoldopam pharmacokinetic and pharmacodynamic profiles in preterm
           infants

        -  Define whether newly identified biomarkers of renal dysfunction are more sensitive
           markers of renal dysfunction following indomethacin than traditional markers including
           urine output and serum creatinine.

      Study design

        -  The study will be a prospective, blinded, randomized, placebo controlled trial.
           Fenoldopam will be started at 0.1 ug/kg/min. If, after 6 hrs there is no decrease in
           blood pressure, the dose will be increased to 0.2 ug/kg/min and continued throughout the
           remainder of the study. The previous study in pediatric patients showed no hypotension
           at a dose of 0.2 ug/kg/min. Fenoldopam will be started 12 hrs before the first dose of
           indomethacin and discontinued 12 hrs after the 3rd dose of indomethacin.

      Describe study population or sample material

        -  preterm infants born at less than or equal to 28 weeks gestation with patent ductus
           arteriosus in whom attempted medical closure with indomethacin is indicated as decided
           upon by the attending physician Sample size/power of primary endpoint

        -  Sample size is 20 patients in each of the two arms (fenoldopam vs placebo) based upon an
           improvement in serum creatinine by one standard deviation.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Changes in urine output (ml/kg/hr)

Condition

Patent Ductus Arteriosus (PDA)

Intervention

Fenoldopam

Study Arms / Comparison Groups

 Control
Description:  Infants in the Placebo arm will receive 0.9% sodium chloride (0.1 ml/hr). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion (in this arm the placebo) will be increased to 0.2 ml/kg/hr. This rate will be continued throughout the remainder of the study.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

40

Start Date

February 6, 2019

Completion Date

December 2022

Primary Completion Date

May 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Gestational age at birth 23 0/7 to 27 6/7 weeks by best obstetrical dating

          2. No previous exposure to indomethacin

          3. Clinical determination to use indomethacin to attempt closure of PDA

          4. No known congenital abnormalities involving the kidneys, heart or lungs

          5. No preexisting renal dysfunction, defined as serum creatinine > 1.0 mg/dl, or urine
             output <1.0 ml/kg/hour over the previous 24 hours.

        Exclusion Criteria:

          1. Enrollment in concurrent study in which interventions may contribute confounding
             variables or have competing outcomes

          2. Infants with antenatally or postnatally diagnosed renal or urinary tract abnormalities

          3. Infants with umbilical cord or infant blood pH below 7.0 at any time before enrollment

          4. Attending physician unwilling to have infant participate in study

          5. Absence of informed consent

Gender

All

Ages

N/A - 28 Days

Accepts Healthy Volunteers

No

Contacts

Jeffrey Segar, MD, 319.356.7244, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02620761

Organization ID

DK113073-01A1

Responsible Party

Principal Investigator

Study Sponsor

Medical College of Wisconsin

Study Sponsor

Jeffrey Segar, MD, Principal Investigator, University of Iowa

Verification Date

December 2019