Clinical trial NCT03558646: Impact of Hydroxocobalamine on Outcome of Smoke Inhalation Injury Admitted to the ICU
Official title: Impact of Hydroxocobalamine on Outcome of Smoke Inhalation Injury Admitted to the ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoke Inhalation Patients
Keywords: Smoke inhalation injury
Acute kidney injury
Intensive care unit
Burns
Prognosis
Hydroxocobalamin
Lead sponsor: Saint-Louis Hospital, Paris, France
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 739
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with smoke inhalation injury admitted in ICU

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.

Eligibility criteria: Inclusion Criteria:

* Admission in ICU with smoke inhalation diagnosed

Exclusion Criteria:

* none

Primary outcomes:
measure: in ICU mortality
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: in ICU acute kidney injury (based on the KDIGO definition)
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: Major Adverse Kidney Events
timeFrame: through study completion, an average of 1 year
measure: in ICU length of stay alive
timeFrame: through study completion, an average of 1 year
Locations:
city: Paris
country: France
facility: Saint-Louis Hospital
state: Ile-De-France
Study officials:
References:
citation: 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
citation: 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.