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NCT02665377 Clinical Trial

Prevention of Akute Kidney Injury, Hearttransplant, ANP

Acute Kidney Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02665377
Other study ID # SahlgrenskaUHMT01
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 25, 2016
Est. completion date January 8, 2022

Study information
Verified date February 2022
Source Sahlgrenska University Hospital, Sweden
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date January 8, 2022
Est. primary completion date January 8, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• ANP

• Placebo

Locations
Country Name City State
Sweden Sahlgrenska sjukhuset Gothenburg

Sponsors (1)
Lead Sponsor Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary GFR 4-5 days after Htx 4-5 days
Secondary GFR 1 year after Htx 1 year
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