Phase 3
Completed N=80
Study to Evaluate if Inhaled Nitric Oxide Improves Liver Function After Transplantation
Reperfusion Injury · liver injury
Source: ClinicalTrials.gov NCT00582010 ↗
Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Nov 2014
Primary outcomePrimary: Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels) — 83; 86.4 percentage change from baseline
Summary
This blinded, placebo-controlled study will administer inhaled nitric oxide to patients undergoing liver transplantation. The purpose of the study is to test if inhaled nitric oxide prevents liver injury associated with the restoration of blood flow. The premise of the current study is provided by previous studies which document a protective effect of inhaled nitric oxide in this clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in AST Levels) |
83; 86.4 | — |
| PRIMARY Changed Rate of Liver Function Recovery Post-transplantation (Percent Change in ALT Levels) |
62.3; 62.4 | — |
| PRIMARY Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Alkaline Phosphatase Levels) |
239.7; 55 | — |
| PRIMARY Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Prothrombin Times (PT)) |
48.9; 25.5 | — |
| PRIMARY Change in Rate of Liver Function Recovery Post-transplantation (Percent Change in Bilirubin Levels) |
6.6; 0.4 | — |
| PRIMARY Change in Rate of Liver Function Recovery Post-transplantation (Decrease in Hepatobiliary Complications) |
2; 5 | — |
| PRIMARY Number of Complications Related to Liver Function Recovery Post-transplantation (Total Complications) at 9 Months Post Surgery |
44; 83 | — |
| SECONDARY Effect of iNO on Hosptial Length of Stay |
9.0; 9.0 | — |
| SECONDARY Effect of iNO on SICU Stay |
2533; 2518 | — |
Eligibility Criteria
Inclusion Criteria
- Patients > 19 yr of age scheduled to undergo liver transplantation.
Exclusion Criteria
- Patients < 19 yr of age
- Patients undergoing re-transplantation or dual organ transplantation
- Patients with underlying pulmonary complications
Data sourced from ClinicalTrials.gov (NCT00582010). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.