Prevention of Akute Kidney Injury, Hearttransplant, ANP

Sahlgrenska University Hospital86 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Acute Kidney Injury

Interventions

ANPDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sahlgrenska sjukhuset

Gothenburg, Sweden

Outcomes

Primary Outcomes

GFR 4-5 days after Htx

Time frame: 4-5 days

Secondary Outcomes

GFR 1 year after Htx

Time frame: 1 year

Data from ClinicalTrials.gov

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