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

Smoke Inhalation Patients Clinical Trial

— COB-AKI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03558646
• Other study ID #: StLouisFrance01
• Status: Completed
• Start date: June 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: April 2019
• Source: Saint-Louis Hospital, Paris, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 739
• Est. completion date: February 1, 2019
• Est. primary completion date: December 31, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Admission in ICU with smoke inhalation diagnosed

Exclusion Criteria:

Related Conditions & MeSH terms

• Respiratory Aspiration
• Smoke Inhalation Injury
• Smoke Inhalation Patients

Intervention

Other:
• There is no intervention planned (observational)
There is no intervention planned (observational)

Locations

Country	Name	City	State
France	Saint-Louis Hospital	Paris	Ile-De-France

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major Adverse Kidney Events	MAKE in ICU or at day 90	through study completion, an average of 1 year
Other	in ICU length of stay alive	through study completion, an average of 1 year	through study completion, an average of 1 year
Primary	in ICU mortality	mortality in ICU or at day 90	through study completion, an average of 1 year
Secondary	in ICU acute kidney injury (based on the KDIGO definition)	AKI in ICU or at day 90	through study completion, an average of 1 year