CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 214 enrolled
Drug / intervention
N-acetylcysteine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01866644
NCT01866644Phase 3Completed

Effectiveness of N-acetylcysteine on Preservation Solution During Liver Transplantation

Instituto de Investigacion Sanitaria La Fe·interventional·Posted May 31, 2013·Updated Aug 13, 2018

In Brief

A Phase 3 clinical trial evaluating N-acetylcysteine and Saline for Unspecified Complication of Liver Transplant. Completed, enrolled 214 participants across 1 site.

Detailed Summary

Evaluate the effectiveness of the administration produced antioxidant N-acetylcysteine (NAC), decreasing the incidence of primary graft dysfunction and primary failure. The degree of dysfunction will be monitored by the method of LIMON, metabonomics techniques and according to the latest published validation Liver Transplantation (16 943-949 2010), total billirrubina greater than 10 mg / dl, INR greater than 1.6 in the seventh postoperative day and alanine or aspartate aminotransferase greater than 2000 IU / L in the first seven days. Liver dysfunction is considered, the presence of a transaminase value\> 2000 IU / L 1-7 postoperative day or BT\> 10 mg / dl or INR\> 1.6, both only in the 7th postoperative day (Olthoff et al Liver Transplantation 16,943 -949 2010).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 31, 2013
Enrollment StartSep 1, 2011
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 13.1 years ago

Interventions

N-acetylcysteinedrug

Bath transplanted liver with N-acetylcysteine

Salinedrug

Bath saline transplanted liver