drugset / Trial / NCT02059460
Perioperative Evaluation of Terlipressin Infusion During Living Donor Liver Transplantation on Incidence of Acute Kidney
Phase 4
Completed
25 enrolled
National Liver Institute, Egypt
Dr. Ayman Alsebaey Qotb Alghoraieb. · collabDr. Khaled Ahmed Yassen · collabDr. Khalid Mousa Abouelenain · collabDr. Mohamed Abdelrauf kandil · collabDr. Mohamed Helmi Ibrahim Afifi · collab
RandomizedSingle-groupOpen-labelPrevention
Summary
To study the impact of intra and post-operative Terlipressin infusion on the occurrence of acute kidney injury after LDLT To investigate perioperative Neutrophil Gelatinase Associated Lipocalin (NGAL) changes and study the effect of Terlipressin on NGAL blood levels
Timeline
- Start
- 2013-05
- Primary completion
- 2016-12
- Completion
- 2016-12
Outcome
Missed primary endpoint
paper Postoperative AKI incidence and NGAL concentrations were comparable (P>.05) between terlipressin and controls groups PMID 28564127 ↗
paper Postliver transplant AKI was not prevented by terlipressin use nor predicted by NGAL levels. PMID 28564127 ↗
Publications
- Background Wong F, Nadim MK, Kellum JA, Salerno F, Bellomo R, Gerbes A, Angeli P, Moreau R, Davenport A, Jalan R, Ronco C, Genyk Y, Arroyo V. Working Party proposal for a revised classification system of renal dysfunction in patients with cirrhosis. Gut. 2011 May;60(5):702-9. doi: 10.1136/gut.2010.236133. Epub 2011 Feb 15.
- Background Hong SH, Lee JM, Choi JH, Chung HS, Park JH, Park CS. Perioperative assessment of terlipressin infusion during living donor liver transplantation. J Int Med Res. 2012;40(1):225-36. doi: 10.1177/147323001204000123.
- Background Saner FH, Canbay A, Gerken G, Broelsch CE. Pharmacology, clinical efficacy and safety of terlipressin in esophageal varices bleeding, septic shock and hepatorenal syndrome. Expert Rev Gastroenterol Hepatol. 2007 Dec;1(2):207-17. doi: 10.1586/17474124.1.2.207.
- Background Mishra J, Ma Q, Prada A, Mitsnefes M, Zahedi K, Yang J, Barasch J, Devarajan P. Identification of neutrophil gelatinase-associated lipocalin as a novel early urinary biomarker for ischemic renal injury. J Am Soc Nephrol. 2003 Oct;14(10):2534-43. doi: 10.1097/01.asn.0000088027.54400.c6.
- Background Rostami Z, Nikpoor M, Einollahi B. Urinary Neutrophil Gelatinase Associated Lipocalin (NGAL) for Early Diagnosis of Acute Kidney Injury in Renal Transplant Recipients. Nephrourol Mon. 2013 Spring;5(2):745-52. doi: 10.5812/numonthly.9385. Epub 2013 Mar 30.
- Background Afonso RC, Hidalgo R, Zurstrassen MP, Fonseca LE, Pandullo FL, Rezende MB, Meira-Filho SP, Ferraz-Neto BH. Impact of renal failure on liver transplantation survival. Transplant Proc. 2008 Apr;40(3):808-10. doi: 10.1016/j.transproceed.2008.02.062.
- Kandil MA, Abouelenain KM, Alsebaey A, Rashed HS, Afifi MH, Mahmoud MA, Yassen KA. Impact of terlipressin infusion during and after live donor liver transplantation on incidence of acute kidney injury and neutrophil gelatinase-associated lipocalin serum levels: A randomized controlled trial. Clin Transplant. 2017 Aug;31(8). doi: 10.1111/ctr.13019. Epub 2017 Jun 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Terlipressin | Peptide | 1 ug/kg | Other |
| Subject | Terlipressin | Peptide | 4 ug/kg | Other |