Trial · NCT00543309

Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery

NCT00543309, Phase 2, Terminated, John M Costello; results first posted 2018-06-25

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery. Trials, record NCT00543309. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00543309

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
NCT number: NCT00543309
Status: Terminated
Phases: Phase 2
Enrollment: 106 participants, actual
Lead sponsor: John M Costello
Conditions: Heart Defects, Congenital
Interventions: nesiritide, milrinone, placebo
First posted: 2007-10-12
Last updated: 2018-06-25
Results first posted: 2018-06-25
Limitations and caveats: Single center design limits generalizability of findings. Study drug doses were extrapolated from published experience in other patient types. Study may have been underpowered to detect differences among treatment groups for secondary outcomes.

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Days Alive and Out of the Hospital Within 30 Days of Surgery.	30 days
Secondary	Cardiovascular: Cardiac Index	Postoperative hour #1	Cardiac index measured using Fick principle with measured oxygen consumption.
Secondary	Cardiovascular: Cardiac Index	Postoperative hour #8	Cardiac index measured using Fick principle with measured oxygen consumption.
Secondary	Cardiovascular: Arrhythmia	Postoperative day (POD) #0 through 5	arrhythmia lasting \>30 seconds or requiring treatment
Secondary	Cardiovascular: Peak Inotrope Score	Initial 24 hours in CICU	Peak Inotrope Score = Doses of dopamine in mcg/kg/minute + dobutamine in mcg/kg/minute + (epinephrine in mcg/kg/minute x 100). The lowest (best) possible Peak Inotrope Score = 0 dose equivalents. There is no maximum Peak Inotrope Score.
Secondary	Cardiovascular: Peak Lactate Level	Initial 24 hours in CICU
Secondary	Renal Function: Urine Output	first 24 hours CICU admit	Volume of urine in mL/kg per day
Secondary	Renal Function: Maximum Change in Serum Creatinine	14 days after surgery
Secondary	Resource Utilization: Hours of Mechanical Ventilation Until Initial Extubation	From Fontan operation until initial extubation, assessed during initial CICU stay, up to 30 days.	Hours of mechanical ventilation until initial extubation following the Fontan operation.
Secondary	Resource Utilization: Days of Initial CICU Stay	From Fontan operation until initial discharge from the CICU, assessed during the postoperative hospitalization, up to 90 days.	Days of initial postoperative CICU care following the Fontan operation.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Days Alive and Out of the Hospital Within 30 Days of Surgery.	30 days		days	MEDIAN
SECONDARY	Cardiovascular: Cardiac Index	Postoperative hour #1	Study patients for whom cardiac index measurements were available.	L/min/m2	MEDIAN
SECONDARY	Cardiovascular: Cardiac Index	Postoperative hour #8	Study patients for whom cardiac index measurements were available.	L/min/m2	MEDIAN
SECONDARY	Cardiovascular: Arrhythmia	Postoperative day (POD) #0 through 5		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Cardiovascular: Peak Inotrope Score	Initial 24 hours in CICU		dose equivalents	MEDIAN
SECONDARY	Cardiovascular: Peak Lactate Level	Initial 24 hours in CICU		mEq/liter	MEDIAN
SECONDARY	Renal Function: Urine Output	first 24 hours CICU admit		mL/kg per day	MEDIAN
SECONDARY	Renal Function: Maximum Change in Serum Creatinine	14 days after surgery		mg/dL	MEDIAN
SECONDARY	Resource Utilization: Hours of Mechanical Ventilation Until Initial Extubation	From Fontan operation until initial extubation, assessed during initial CICU stay, up to 30 days.		hours	MEDIAN
SECONDARY	Resource Utilization: Days of Initial CICU Stay	From Fontan operation until initial discharge from the CICU, assessed during the postoperative hospitalization, up to 90 days.		days	MEDIAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group72

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Days Alive and Out of the Hospital Within 30 Days of Surgery.	I- Nesiritide	20	Full Range 0 to 24	days
Days Alive and Out of the Hospital Within 30 Days of Surgery.	II- Milrinone	18	Full Range 0 to 23	days
Days Alive and Out of the Hospital Within 30 Days of Surgery.	III- Placebo	20	Full Range 0 to 23	days
Cardiovascular: Cardiac Index	I- Nesiritide	3.5	Full Range 1.5 to 6.1	L/min/m2
Cardiovascular: Cardiac Index	II- Milrinone	2.8	Full Range 1.6 to 6.3	L/min/m2
Cardiovascular: Cardiac Index	III- Placebo	2.5	Full Range 1.5 to 6.1	L/min/m2
Cardiovascular: Cardiac Index	I- Nesiritide	3.2	Full Range 0.6 to 6.7	L/min/m2
Cardiovascular: Cardiac Index	II- Milrinone	2.9	Full Range 0.9 to 5.9	L/min/m2
Cardiovascular: Cardiac Index	III- Placebo	2.5	Full Range 1.0 to 5.5	L/min/m2
Cardiovascular: Arrhythmia	I- Nesiritide	16		Participants

1 to 10 of 72Source ClinicalTrials.gov

See all 72 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	I- Nesiritide	35
Overall Study	STARTED	II- Milrinone	36
Overall Study	STARTED	III- Placebo	35
Overall Study	COMPLETED	I- Nesiritide	35
Overall Study	COMPLETED	II- Milrinone	35
Overall Study	COMPLETED	III- Placebo	35
Overall Study	NOT COMPLETED	I- Nesiritide	0
Overall Study	NOT COMPLETED	II- Milrinone	1
Overall Study	NOT COMPLETED	III- Placebo	0

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Hypotension	Cardiac disorders	I- Nesiritide	24	35
other	Hypotension	Cardiac disorders	II- Milrinone	27	36
other	Hypotension	Cardiac disorders	III- Placebo	24	35
other	Acute renal insufficiency	Renal and urinary disorders	I- Nesiritide	2	35
other	Acute renal insufficiency	Renal and urinary disorders	II- Milrinone	1	36
other	Acute renal insufficiency	Renal and urinary disorders	III- Placebo	3	35

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	I- Nesiritide	1	35
Total, all-cause mortality	II- Milrinone	0	36
Total, all-cause mortality	III- Placebo	0	35
Total, other adverse events	I- Nesiritide	24	35
Total, other adverse events	II- Milrinone	27	36
Total, other adverse events	III- Placebo	24	35
Total, serious adverse events	I- Nesiritide	0	35
Total, serious adverse events	II- Milrinone	0	36
Total, serious adverse events	III- Placebo	0	35

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24906491	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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