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Prevention of Akute Kidney Injury, Hearttransplant, ANP

Phase 3
Completed
Conditions
Acute Kidney Injury
Interventions
Drug: Placebo
Registration Number
NCT02665377
Lead Sponsor
Sahlgrenska University Hospital, Sweden
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
86
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlaceboInfusion of NaCl at the same volyme as for ANP for 5 days.
ANPANPInfusion of h-ANP at dose of 50ng/kg/min fore 5 days, starting at the induction of anesthesia.
Primary Outcome Measures
NameTimeMethod
GFR 4-5 days after Htx4-5 days
Secondary Outcome Measures
NameTimeMethod
GFR 1 year after Htx1 year

Trial Locations

Locations (1)

Sahlgrenska sjukhuset

🇸🇪

Gothenburg, Sweden

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