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Prevention of Akute Kidney Injury, Hearttransplant, ANP

Primary Purpose

Acute Kidney Injury

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
ANP
Placebo
Sponsored by
Sahlgrenska University Hospital, Sweden
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Kidney Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sahlgrenska sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ANP

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

GFR 4-5 days after Htx

Secondary Outcome Measures

GFR 1 year after Htx

Full Information

First Posted
January 22, 2016
Last Updated
February 8, 2022
Sponsor
Sahlgrenska University Hospital, Sweden
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1. Study Identification

Unique Protocol Identification Number
NCT02665377
Brief Title
Prevention of Akute Kidney Injury, Hearttransplant, ANP
Official Title
Prevention of Akute Kidney Injury With Human Atrial Natriuretic Peptide in Patients Undergoing Heart Transplant.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 25, 2016 (Actual)
Primary Completion Date
January 8, 2022 (Actual)
Study Completion Date
January 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ANP
Arm Type
Active Comparator
Arm Description
Infusion of h-ANP at dose of 50ng/kg/min fore 5 days, starting at the induction of anesthesia.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Infusion of NaCl at the same volyme as for ANP for 5 days.
Intervention Type
Drug
Intervention Name(s)
ANP
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
GFR 4-5 days after Htx
Time Frame
4-5 days
Secondary Outcome Measure Information:
Title
GFR 1 year after Htx
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven-Erik Ricksten, Prof
Organizational Affiliation
Sahlgrenska universitetssjukhuset
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sahlgrenska sjukhuset
City
Gothenburg
ZIP/Postal Code
413 45
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Prevention of Akute Kidney Injury, Hearttransplant, ANP

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