Impact of Hydroxocobalamine on Outcome of Smoke Inhalation Injury Admitted to the ICU

Completed

• Conditions: Smoke Inhalation Patients

• Registration Number: NCT03558646
• Lead Sponsor: Saint-Louis Hospital, Paris, France

Brief Summary

In Europe, hydroxocobalamin (cyanokit) has been used for suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). However, the impact of hydroxocobalamin on outcome has never been thoroughly evaluated. While hydroxocobalamin has long been presented as being side-effect free, recent data suggest that in patients with severe burns, its use was associated with the occurrence of acute renal failure by intra tubular precipitation of oxalate crystals (2, 3). The purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation.

Detailed Description

In Europe, hydroxocobalamin (cyanokit) is the antidote recommended by expert consensus in cases of suspicion of cyanide intoxication associated with the inhalation of fire smoke (1). However, cyanokit has never been evaluated in this indication. Clinical data suggest that in patients with severe burns, its use is associated with the occurrence of acute kidney injury by intra tubular precipitation of oxalate crystals (2, 3). The purpose of this observational study is to investigate the association between use of hydroxocobalamin and outcome after smoke inhalation. The results of this study should guide future research and advice on the benefit-risk ratio of hydroxocobalamin.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2018-06-01
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Primary Completion: 2018-12-31
• Study Completion: 2019-02-01
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 739

Inclusion Criteria

• Admission in ICU with smoke inhalation diagnosed

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
in ICU mortality	through study completion, an average of 1 year	mortality in ICU or at day 90

Secondary Outcome Measures

Name	Time	Method
in ICU acute kidney injury (based on the KDIGO definition)	through study completion, an average of 1 year	AKI in ICU or at day 90

Trial Locations

Locations (1)

Saint-Louis Hospital; 🇫🇷 Paris, Ile-De-France, France