Does Terlipressin Improve Renal Outcome After Liver Surgery (TIROL)

University of Zurich (UZH)

Status and phase: Withdrawn; Phase 2

Conditions: Kidney Failure

Treatments: Drug: Placebo; Drug: Terlipressin

Study type: Interventional

Funder types: Other

Identifiers

NCT02368249

2012-0581

Details and patient eligibility

About

The investigators aim to address whether terlipressin improves the renal outcome after liver surgery. Therefore the investigators are planning to conduct a double-blinded randomized control trial. The investigators will randomize patients undergoing any kind of liver surgery and being at increased moderate to high risk for post-operative acute renal failure into a control group receiving post- operative a placebo or into a group receiving post-operatively terlipressin in combination with human albumin.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >=12% risk for post-operative ARF on our recently developed and validated prediction score for ARF after liver surgery, patients will need five points or more in the pre-operative assessment of the predictors to be enrolled in the trial

Exclusion criteria

• < 18 years
• liver cirrhosis
• coronary insufficiency with ST-elevation or ST-depression in the - - intra-operative ECG as signs of an acute coronary syndrome
• pregnancy and breast feed

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function

Treatment:

Drug: Placebo

Terlipressin Group

Experimental group

Description:

Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function

Treatment:

Drug: Terlipressin