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Completed

NCT Number: NCT03558646

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

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.

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Key information

Conditions

Smoke Inhalation Patients Acute Kidney Injury Burns Burns, Inhalation Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Smoke Inhalation Injury Urogenital Diseases Urologic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Saint-Louis Hospital

Paris, Île-de-France Region, 75010, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Admission in ICU with smoke inhalation diagnosed

Exclusion criteria

  • none

Treatment and study plan

There is no intervention planned (observational)

Other

There is no intervention planned (observational)

Primary outcomes

  1. in ICU mortality

    Time frame: through study completion, an average of 1 year

    mortality in ICU or at day 90

Secondary outcomes

  1. in ICU acute kidney injury (based on the KDIGO definition)

    Time frame: through study completion, an average of 1 year

    AKI in ICU or at day 90

Other outcomes

  1. Major Adverse Kidney Events

    Time frame: through study completion, an average of 1 year

    MAKE in ICU or at day 90

  2. in ICU length of stay alive

    Time frame: through study completion, an average of 1 year

    through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Saint-Louis Hospital, Paris, France

Other

Registry information

Acronym: COB-AKI

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 15, 2018
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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