Remote Ischemic Preconditioning and Acute Kidney Injury in HTX

NCT05364333 | Completed DMC

• 1 other identifier: 2020-1240
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

orthotopic heart transplantation; HTX

Outcome Measures

Primary Outcomes (1)

• postoperative TIMP2-IGFBP7 concentration

  change in postoperative TIMP2-IGFBP7 concentration measured in urine of patients

  first 48 hours after HTX (arrival ICU, 24 hours after HTX, 48 hours after HTX)

Secondary Outcomes (5)

• Postoperative urinary biomarker concentration

  first 48 hours after HTX (arrival ICU, 24 hours after HTX, 48 hours after HTX)

• AKI and renal replacement therapy

  first 72 hours

• Major adverse kidney events (MAKE)

  during 30 days after HTX

• Major adverse cardiovascular events (MACE)

  during 30 days after HTX

• Days alive and out of hospital

  during 30 days after HTX

Study Arms (2)

Sham RIPC

SHAM COMPARATOR

Control patients will be submitted to 3 cycles of sham RIPC. Each cycle of Sham RIPC consists of a pseudo ischemia of the left upper limb caused by inflating a blood pressure cuff to 20mmHg for 5 minutes followed by 5 minutes of reperfusion time.

Procedure: Remote ischemic preconditioning

RIPC

EXPERIMENTAL

Patients in the intervention group will be submitted to 3 cycles of RIPC. For each cycle of RIPC, a blood pressure cuff will be inflated at 200mmHg for 5 minutes (or at least 50mmHg above the systolic arterial blood pressure) followed by 5 minutes of reperfusion time.

Procedure: Remote ischemic preconditioning

Interventions

Remote ischemic preconditioning PROCEDURE

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

RIPC; Sham RIPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- adult patients (\>18 years) undergoing HTX

You may not qualify if:

• Acute myocardial infarction up to 7 days before surgery
• age younger than 18 years
• pre-existing AKI
• previous kidney transplantation
• chronic kidney disease with a glomerular filtration rate less than 30ml/min
• pregnancy
• peripheral vascular disease affecting the upper limbs
• hepato-renal syndrome
• drug therapy with sulfonamide or nicorandil

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (1)

University Hospital Duesseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Study Officials

• René M'Pembele, M.D.

  Heinrich-Heine University, Duesseldorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2022
• First Posted: May 6, 2022
• Study Start: June 1, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)