Remote Ischemic Preconditioning (RIPC) versus sham-control for reduction of ischemia-reperfusion injury of the Liver after liver surgery in patients with pre-damaged liver: a prospective, randomized controlled, triple-blind, clinical phase III monocenter trial

Remote Ischemic Preconditioning (RIPC) versus sham-control for reduction of ischemia-reperfusion injury of the Liver after liver surgery in patients with pre-damaged liver: a prospective, randomized controlled, triple-blind, clinical phase III monocenter trial - RIPL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00018931

Enrollment

102

Registered

2019-11-22

Start date

2019-12-02

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K74.6 K72.0

Interventions

Group 1: Experimental Arm/ Study Intervention: In RIPC, a blood pressure cuff is placed around an arm immediately prior to surgery (after induction of anesthesia and before/ during incision/dissection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Persons meeting the following criteria may be included in the study: • Known pre-damage to the liver (e.g. liver cirrhosis (Child Pugh A and B), steatosis, fibrosis, s/p chemotherapy, other pathologies leading to liver damage) • Planned elective liver resection or dissection of the liver tissue (so-called "in situ split") with subsequent resection • Signed informed consent • Age =18 years

Exclusion criteria

Exclusion criteria: Persons meeting any of the following criteria cannot be included in the study: • Patients not able to give informed consent • Liver cirrhosis Child Pugh C • Patients presenting with the following contraindications to the study intervention (RIPC): arterial occlusive disease (AOD), infections or wounds on the upper extremity, poorly controlled diabetes mellitus, or deep vein thrombosis of the upper extremity • Patients in whom a Pringle maneuver is unlikely due to the type of procedure or extent of resection (e.g. very small and/or peripheral resections)

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the level of the serum transaminases (alanine aminotransferase, ALAT, and aspartate aminotransferase, ASAT) on the first postoperative day (= POD 1). These blood samples are all routinely taken, as predetermined in the clinic's own pathway for liver resections, and therefore do not constitute study-related measures.	—

Secondary

Measure	Time frame
Secondary endpoints are: complications according to Clavien Dindo, reinterventions, hospital stay, and readmission. Moreover, effects of RIPC on biomarkers of ischemia-reperfusion injury (serotonin, VEGF) and necrotic cell death (Hmgb1) will be measured in plasma before RIPC (t0), immediately after RIPC (t1), and at 3 hours after RIPC (t2) using ELISA.	—

Countries

Germany

Contacts

Public ContactJulia Hardt

Universität Heidelberg, Medizinische Fakultät Mannheim, Chirurgische Klinik

julia.hardt@umm.de0621-383-2225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 9, 2026