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no focus on this topic
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Patients receiving post-operative placebo (Ringer lactate solution) treatment to preserve the renal function |
|
| Terlipressin Group | Experimental | Patients receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Terlipressin | Drug | Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function |
|
| Measure | Description | Time Frame |
|---|---|---|
| serum creatinine peak level within 48 hours post-operative | within 48 hours post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| the urinary output/24h | Post Operative Day 0 to 3 | |
| Need for hemofiltration and/or hemodialysis | participants will be followed for the duration of hospital stay, an expected average of 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre-Alain Clavien, MD PhD | Departement of Visceral and Transplantation Surgery Zurich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral and Transplantation Surgery of the University Hospital of Zurich | Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077585 | Terlipressin |
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D008236 | Lypressin |
| D014667 | Vasopressins |
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
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|
| Placebo | Drug | Patients are receiving a post-operative intravenous Ringer's lactate solution |
|
|
| Post Operative Day 0 - 14 |
| Morbidity & mortality | measured by the comprehensive complication index; participants will be followed for the duration of hospital stay, an expected average of 14 days | Post Operative Day 0 - 14 |
| Liver function | assessed by serum levels of aspartate aminotransferase (AST) and alanine aminotransferase (ALT) | Post Operative Day 0 - 5 |
| length of hospital stay | in days; participants will be followed for the duration of hospital stay, an expected average of 14 days | Post Operative Day 0 - 14 |
| length of ICU stay | in days; participants will be followed for the duration of ICU stay, an expected average of 7 days | Post Operative Day 0 - 7 |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D036361 |
| Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |