Prevention of Akute Kidney Injury, Hearttransplant, ANP

Sahlgrenska University Hospital

Status and phase: Completed; Phase 3

Conditions: Acute Kidney Injury

Treatments: Drug: ANP; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02665377

SahlgrenskaUHMT01

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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86 participants in 2 patient groups, including a placebo group

ANP

Active Comparator group

Description:

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

Treatment:

Drug: ANP

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo