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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03558646
Acronym
COB-AKI
Enrollment
739
Registered
2018-06-15
Start date
2017-06-01
Completion date
2019-02-01
Last updated
2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoke Inhalation Patients

Keywords

Smoke inhalation injury, Acute kidney injury, Intensive care unit, Burns, Prognosis, Hydroxocobalamin

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.

Interventions

There is no intervention planned (observational)

Sponsors

Saint-Louis Hospital, Paris, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Admission in ICU with smoke inhalation diagnosed

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
in ICU mortalitythrough study completion, an average of 1 yearmortality in ICU or at day 90

Secondary

MeasureTime frameDescription
in ICU acute kidney injury (based on the KDIGO definition)through study completion, an average of 1 yearAKI in ICU or at day 90

Other

MeasureTime frameDescription
Major Adverse Kidney Eventsthrough study completion, an average of 1 yearMAKE in ICU or at day 90
in ICU length of stay alivethrough study completion, an average of 1 yearthrough study completion, an average of 1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026