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OpenTrials
Completed

NCT Number: NCT02665377

Prevention of Akute Kidney Injury, Hearttransplant, ANP

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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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sahlgrenska sjukhuset

Gothenburg, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ANP

Drug

Placebo

Drug

Primary outcomes

  1. GFR 4-5 days after Htx

    Time frame: 4-5 days

Secondary outcomes

  1. GFR 1 year after Htx

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

Prevention of Akute Kidney Injury With Human Atrial Natriuretic Peptide in Patients Undergoing Heart Transplant.

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2016
Registry last updated
Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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