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

NCT ID: NCT03558646

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 739 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-02-01

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.

Conditions

Smoke Inhalation Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

There is no intervention planned (observational)

There is no intervention planned (observational)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Admission in ICU with smoke inhalation diagnosed

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Saint-Louis Hospital, Paris, France

OTHER

Sponsor Role: lead

Responsible Party

Dr François Dépret

Chef de clinique assistant of the surgical critical burn unit, Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Saint-Louis Hospital

Paris, Île-de-France Region, France

Countries

France

References

1. Anseeuw K, Delvau N, Burillo-Putze G, et al.: Cyanide poisoning by fire smoke inhalation: a European expert consensus. Eur J Emerg Med 2013; 20:2-9 2. for the PRONOBURN Study Group, Legrand M, Michel T, et al.: Risk of oxalate nephropathy with the use of cyanide antidote hydroxocobalamin in critically ill burn patients. Intensive Care Medicine 2016; 42:1080-1081 3. Legrand M, Michel T: Empiric use of hydroxocobalamin in patients with smoke inhlation injury: Not so fast! Burns 2017; 43:886

Reference Type: BACKGROUND

Depret F, Hoffmann C, Daoud L, Thieffry C, Monplaisir L, Creveaux J, Annane D, Parmentier E, Mathieu D, Wiramus S, Demeure DIt Latte D, Kpodji A, Textoris J, Robin F, Klouche K, Pontis E, Schnell G, Barbier F, Constantin JM, Clavier T, du Cheyron D, Terzi N, Sauneuf B, Guerot E, Lafon T, Herbland A, Megarbane B, Leclerc T, Mallet V, Pirracchio R, Legrand M. Association between hydroxocobalamin administration and acute kidney injury after smoke inhalation: a multicenter retrospective study. Crit Care. 2019 Dec 23;23(1):421. doi: 10.1186/s13054-019-2706-0.

Reference Type: DERIVED

PMID: 31870461 (View on PubMed)

Other Identifiers

StLouisFrance01

Identifier Type: -

Identifier Source: org_study_id