Trial Outcomes & Findings for Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants (NCT NCT02620761)

NCT ID: NCT02620761

Last Updated: 2022-09-16

Results Overview

Urine will be collected and measured in 6 hour increments beginning 6 hours prior to starting fenoldopam or placebo infusion. The first dose of indomethacin will be given 12 hours after starting fenoldopam or placebo. Two additional doses of indomethacin will be given 12 hours apart. Urine will continue to be collected and volume measured in 6 hour increments up to 24 hrs after the last dose of indomethacin. To summarize, urine will be collected and measured from time -6 hours to 0 hours. Fenoldapam or placebo will be initiated at time 0 hrs, indomethacin given at time 12, 24 and 36 hours, and urine collected and measured to time 60 hours.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 1 participants
• Primary outcome timeframe: 66 hrs - from 6 hrs before beginning of fenoldopam or placebo infusion up to 24 hours after the last dose of indomethacin
• Results posted on: 2022-09-16

Participant Flow

Participant milestones

Measure	Control 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. 0.9%NS: Randomized to receive Fenoldopam or 0.9%NS	Fenoldopam Infants in the experimental arm will receive fenoldopam (60 ug/ml; 0.1 ml/hr to provide 0.1ug/kg/min). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion will be increased to 0.2 ml/kg/hr (0.2 ug/kg/min for infants receiving fenoldopam). This rate will be continued throughout the remainder of the study. Fenoldopam: Randomized to receive Fenoldopam or 0.9%NS
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fenoldopam to Prevent Renal Dysfunction in Indomethacin Treated Preterm Infants

Baseline characteristics by cohort

Measure	Control n=1 Participants 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. 0.9%NS: Randomized to receive Fenoldopam or 0.9%NS	Fenoldopam Infants in the experimental arm will receive fenoldopam (60 ug/ml; 0.1 ml/hr to provide 0.1ug/kg/min). If, after 6 hrs there is not a clinically concerning decrease in blood pressure, as determined by attending physician, the rate of infusion will be increased to 0.2 ml/kg/hr (0.2 ug/kg/min for infants receiving fenoldopam). This rate will be continued throughout the remainder of the study. Fenoldopam: Randomized to receive Fenoldopam or 0.9%NS	Total n=1 Participants Total of all reporting groups
Age, Continuous	25 weeks gestation STANDARD_DEVIATION 0 • n=5 Participants	—	25 weeks gestation STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 66 hrs - from 6 hrs before beginning of fenoldopam or placebo infusion up to 24 hours after the last dose of indomethacin

Population: No analysis performed as only single patient was enrolled

Urine will be collected and measured in 6 hour increments beginning 6 hours prior to starting fenoldopam or placebo infusion. The first dose of indomethacin will be given 12 hours after starting fenoldopam or placebo. Two additional doses of indomethacin will be given 12 hours apart. Urine will continue to be collected and volume measured in 6 hour increments up to 24 hrs after the last dose of indomethacin. To summarize, urine will be collected and measured from time -6 hours to 0 hours. Fenoldapam or placebo will be initiated at time 0 hrs, indomethacin given at time 12, 24 and 36 hours, and urine collected and measured to time 60 hours.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 hours

Population: No analysis performed as only single patient was enrolled

Blood samples for determination of serum fenoldopam levels will be obtained immediately prior to starting the infusion of fenoldopam (time 0 hour), continue through the 48 hour period of fenoldopam infusion and continue for an additional 12 hours after stopping the fenoldopam infusion.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hours

Population: No analysis performed as only single patient was enrolled

Serum creatinine will be measured immediately prior to first dose of indomethacin, immediately prior to the third dose of indomethacin (24 hr later) and 24 hours after the third dose of indomethacin

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 hours

Population: No analysis performed as only single patient was enrolled

We will relate serum levels of fenoldopam to changes in urine volume over the duration of time of fenoldopam infusion and after discontinuation of infusion. This constitutes part of the pharmacodynamic analysis

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 60 hours

Population: No analysis performed as only single patient was enrolled

We will relate serum levels of fenoldopam to serum creatinine values over the duration of time of fenoldopam infusion and after discontinuation of infusion. This constitutes part of the pharmacodynamic analysis

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hr

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hr

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hr

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 48 hrs

Population: No analysis performed as only single patient was enrolled

Period from just prior to first dose of indomethacin (time point 12 hours) to 24 hours beyond last dose of indomethacin ( which is time point 60 hours). Thus, this aspect of study takes place between time point 12 hr and time point 60 hr, which is a 48 hour period

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fenoldopam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Segar

Medical College of Wisconsin

Phone: 14143377702

Email: jsegar@mcw.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place