Impact of %6 HES 130/0.4 and %4 Gelofusine Infusion on Kidney Function in the Living-donor Liver Transplantation

NCT02079350 | Completed

• 1 other identifier: 11739
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Although the negative impacts of colloid solutions with high molecular weight on renal functions, combination of lower molecular weight colloid varieties with crystalloid solutions and its use during intraoperative period have been subject to current research. Since the first liver transplantation, pre-or post-transplantation renal problems are still among the main causes of mortality and morbidity. The aim of the study was to evaluate the effects of fluid replacement solutions used intraoperatively on renal functions in elective living-donor liver transplantation.This study was approved by the Ethics Committee of Hospital and all patients were informed and gave written consent. Participants were patients scheduled for elective living-donor liver transplantation. Patients with normal renal function were randomly allocated to infusion with 6% HES 130/0.4 (HES Group) and 4% Gelofusine (GEL Group). Blood samples were obtained before induction of anesthesia (baseline), at the end of the operation, and postoperative days 1 and 4. Different eGFR formulas using creatinine (MDRD, CKD-EPI, and Cockraud Gault) were used to calculate estimated glomerular filtration rates.

Conditions

Patients Undergoing Liver Transplantation

Outcome Measures

Primary Outcomes (1)

• renal dysfunction

  1 month

Secondary Outcomes (1)

• mortality

  1 month

Study Arms (2)

%4 Gelofusine

patients administered %4 Gelofusine during liver transplantation

Drug: %6 HES and %4 Gelofusine

%6 HES

patients administered %6 HES during liver transplantation

Drug: %6 HES and %4 Gelofusine

Interventions

%6 HES and %4 Gelofusine DRUG

%4 Gelofusine; %6 HES

Eligibility Criteria

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

Study Population

patients undergoing living donor liver transplantation

You may qualify if:

• Normal kidney function

You may not qualify if:

• anormal kidney function
• cadaveric transplantation
• emergency operation
• patients less than 18 years old

Sponsors & Collaborators

• Turkiye Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

Turkey Yuksek Ihtisas Education and Research Hospital, Anesthesiology Clinic

Ankara, 06550, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: March 1, 2014
• First Posted: March 5, 2014
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 5, 2014

Record last verified: 2014-03

Locations

TU (1)