ClinicalTrials.gg
CompletedNCT03558646COB-AKIUpdated Apr 4, 2019

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

An observational study in Smoke Inhalation Patients, sponsored by Saint-Louis Hospital, Paris, France. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-04.

Sponsored by Saint-Louis Hospital, Paris, France · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
739
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 154 studies in Acute Kidney Injury with a site in France — 31 open to participants now, 35 under way, 4 of them phase 3. Acute Kidney Injury · France.

Enrollment
14th of 76
739 · median 190
Started
2017
with 6 others
Observational
76 of 154
13 open now
Registered
56th of 154
by date

Among the 154 studies in Acute Kidney Injury with a site in France, this one is the 14th largest by enrollment of the 76 observational ones that give a count, is one of 7 that started in 2017, is one of 76 observational ones, and was the 56th registered.

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 394 are open to participants now.

Browse Acute Kidney Injury studies →

Open to participants now

31 of the 154 studies in Acute Kidney Injury with a site in France are open now. Recruiting first, the newest first:

26 more — sign in →

All 31 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 230 Acute Kidney Injury studies recruiting now, 161 (70%) set no upper age limit and 36 (16%) stop at 75 or younger; 22 take children under 18; 25 take healthy volunteers.

This study: 18 Years and older · all sexes.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Smoke Inhalation Patients

Keywords

  • Smoke inhalation injury
  • Acute kidney injury
  • Intensive care unit
  • Burns
  • Prognosis
  • Hydroxocobalamin
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with smoke inhalation injury admitted in ICU

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Admission in ICU with smoke inhalation diagnosed

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
739 participants (actual)
Patient registry
No

Interventions

  • OtherThere is no intervention planned (observational)

    There is no intervention planned (observational)

06

What researchers measure

Primary outcomes

  1. in ICU mortality

    mortality in ICU or at day 90

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

Secondary outcomes

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

    AKI in ICU or at day 90

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

Other outcomes

  1. Major Adverse Kidney Events

    MAKE in ICU or at day 90

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

  2. in ICU length of stay alive

    through study completion, an average of 1 year

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

07

Study locations

1 site
  • Saint-Louis Hospital
    Paris, Ile-De-France 75010, France
08

References and documents

Publications

  • 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
  • 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. PubMed 31870461 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2017 to primary completion in Dec 2018, 18 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 1, 2018
First posted
Jun 15, 2018
StartActual
Jun 1, 2017
Primary completionActual
Dec 31, 2018
CompletionActual
Feb 1, 2019
Last update
Apr 4, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 4, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03558646
Lead sponsor
Saint-Louis Hospital, Paris, France
Responsible party
Dr François Dépret (Chef de clinique assistant of the surgical critical burn unit, Principal investigator, Saint-Louis Hospital, Paris, France) — Principal investigator
First posted
Jun 15, 2018
Start date
Jun 1, 2017
Primary completion
Dec 31, 2018
Completion
Feb 1, 2019
Last update
Apr 4, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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