Perioperative Evaluation of Terlipressin Infusion During Living Donor Liver Transplantation on Incidence of Acute Kidney

NCT02059460 | Completed Phase 4 DMC

• 1 other identifier: Terli-NGAL-111
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Acute Kidney Injury; Liver Transplantation; Terlipressin; NGAL

Keywords

Terlipressin; Acute kidney injury; Liver transplantation; NGAL

Outcome Measures

Primary Outcomes (1)

• Development of acute kidney injury

  it is elevation of serum creatinine \>1.5 mg/dL

  5 days postoperatuvely

Study Arms (2)

Terlipressin group

EXPERIMENTAL

Terlipressin group, Terlipressin (Glypressin®, Rentschler biotechnology Gmbh, Erwin, Germany) will be started by continuous infusion at a dose of 1-4 µg/kg/h till day 4 postoperatively

Drug: Terlipressin

Control group

PLACEBO COMPARATOR

Drug: placebo

Interventions

Terlipressin DRUG

Terlipressin (Glypressin®) will be started by continuous infusion at a dose of 1-4 µg/kg/h till day 4 postoperatively

Also known as: Glypressin

Terlipressin group

placebo DRUG

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult living donor liver transplant recipients with no preoperative renal dysfunction

You may not qualify if:

• patients with renal insufficiency defined as serum creatinine \> 2 mg/dl and GFR \<60 ml/min by isotope scanning of the kidney.

Sponsors & Collaborators

• National Liver Institute, Egypt: lead
• Dr. Mohamed Helmi Ibrahim Afifi: collaborator
• Dr. Khaled Ahmed Yassen: collaborator
• Dr. Khalid Mousa Abouelenain: collaborator
• Dr. Mohamed Abdelrauf kandil: collaborator
• Dr. Ayman Alsebaey Qotb Alghoraieb.: collaborator

Study Sites (1)

National Liver Institute

Shebeen Alkom, Monufia Governorate, 32511, Egypt

Location

Related Publications (7)

• 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.

  PMID: 21325171 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.

  PMID: 22429362 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.

  PMID: 19072411 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.

  PMID: 14514731 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.

  PMID: 23841038 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.

  PMID: 18455024 BACKGROUND

• 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.

  PMID: 28564127 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Terlipressin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lypressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Hanaa S Rashed, MSc

  National Liver Institute, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Anesthesia and Intensive Care

Study Record Dates

• First Submitted: November 10, 2013
• First Posted: February 11, 2014
• Study Start: May 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

EG (1)