drugset / Trial / NCT01785082

Fast-track LiveR: Study for the Early Identification of Low-risk Patients After Partial Liver Resection by the LiMAx-test

NCT01785082 ↗

Phase 3 Completed 149 enrolled Humedics GmbH
RandomizedParallel-groupOpen-labelDiagnostic

Summary

The purpose of this study is to investigate safety and efficacy of intravenously injected 0.4% 13-C-Methacetin solution for the determination of liver function with the LiMAx-test on patients with partial liver resection. The LiMAx-test is compared with an untreated control group and post-surgical management of both groups is investigated.

Timeline

Start
2013-01
Primary completion
2015-09
Completion
2015-09

Outcome

Met primary endpoint

paper Thirty-six of 58 patients (62 per cent) in the LiMAx® group were transferred directly to a general ward, compared with one of 60 (2 per cent) PMID 30263981 ↗

paper compared with one of 60 (2 per cent) in the control group (P < 0·001). PMID 30263981 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject 13C-Methacetin Diagnostic / imaging agent 2 mg/kg Intravenous

Indications