Does Terlipressin Improve Renal Outcome After Liver Surgery

Condition(s) targeted: Kidney Failure

Intervention: Terlipressin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Zurich

Official(s) and/or principal investigator(s):
Pierre-Alain Clavien, MD PhD, Study Director, Affiliation: Departement of Visceral and Transplantation Surgery Zurich

Overall contact:
Ksenija Slankamenac, MD PhD, Phone: 0041 44 255 11 11, Email: ksenija.slankamenac@usz.ch

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.

Official title: Does Terlipressin Improve Renal Outcome After Liver Surgery - A Double-Blinded Randomized Control Trial (TIROL-Trial)

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Primary outcome: serum creatinine peak level within 48 hours post-operative

Secondary outcome:

the urinary output/24h

Need for hemofiltration and/or hemodialysis

Morbidity & mortality

Liver function

length of hospital stay

length of ICU stay

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Ksenija Slankamenac, MD PhD, Phone: 0041 44 255 11 11, Email: ksenija.slankamenac@usz.ch

Department of Visceral and Transplantation Surgery of the University Hospital of Zurich, Zurich 8091, Switzerland; Recruiting
Ksenija Slankamenac, MD PhD, Phone: +41 44 255 11 11, Email: ksenija.slankamenac@usz.ch

Starting date: February 2015
Last updated: February 20, 2015