Prevention of Akute Kidney Injury, Hearttransplant, ANP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-25

Study Completion Date

2022-01-08

Brief Summary

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Prospective, blinded, placebo-controlled trial. Patients: Adult patients (\>18 years of age) undergoing de novo Htx, with a preoperative GFR \> 30ml/min, not receiving an ABO-incompatible organ with an ischemia time of \> 6 hours. A donor age \> 70 years is an exclusion criteria.

Intervention: Infusion of h-ANP fore five days, starting at the induction of anesthesia.

Outcome: Kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5 Days after Htx plus after 3 and 12 months.

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Detailed Description

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Conditions

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Acute Kidney Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ANP

Infusion of h-ANP at dose of 50ng/kg/min fore 5 days, starting at the induction of anesthesia.

Group Type ACTIVE_COMPARATOR

ANP

Intervention Type DRUG

Placebo

Infusion of NaCl at the same volyme as for ANP for 5 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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ANP

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* De novo Htx.
* Preoperative GFR \> 30ml/min/1,73m2.
* \>18 years old.
* Written consent.

Exclusion Criteria

* Multi organ transplantation or previous heart transplant.
* ECMO
* Donor age \> 70 years.
* Dialysis.
* ABO-incompatible organ.
* Donor heart ischemia time \> 6 tim.
* Known kidney disease.
* Other planed study within 2 mounth.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No