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Remote Ischemic Preconditioning and Acute Kidney Injury in HTX

NCT05364333 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-01

No results posted yet for this study

Summary

Postoperative Acute Kidney Injury (AKI) is a common complication after heart transplantation (HTX) affecting outcome of patients. Remote ischemic preconditioning (RIPC) is an intervention that showed positive effect on incidence of AKI in elective cardiac surgery. Effects of RIPC on AKI in HTX patients have not been investigated to date. Recently new biomarkers have been established, showing high sensitivity and specificity for AKI. Especially, Insulin-Like Growth Factor Binding Protein 7 (IGFBP7) together with Tissue Inhibitor of Metalloproteinases-2 (TIMP-2), known as nephrocheck®, are diagnostic biomarkers in this context. Hence, the investigators want to conduct a randomized controlled feasibility and proof of concept trial to determine the effects of RIPC on AKI after HTX, defined/detected using postoperative urinary \[TIMP-2\]\*\[IGFBP-7\] concentration.

Conditions

  • Heart Transplantation

Interventions

PROCEDURE

Remote ischemic preconditioning

For each cycle of RIPC, a blood pressure cuff will be inflated to the non-dominant arm at 200mmHg for 5 minutes (or at least 50mmHg above the systolic arterial blood pressure) followed by 5 minutes of reperfusion time

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • René M'Pembele, M.D. · Heinrich-Heine University, Duesseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-04-30
Completion
2024-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05364333 on ClinicalTrials.gov