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Alpha-ketoglutarate infusion to treat cyanide overload

An open labeled, comparative, step-up phase-2 clinical study to assess bioavailability and efficacy of sodium alpha-ketoglutarate infusion injection in patients with cyanide overload

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/02/003355
Enrollment
524
Registered
2013-02-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Cyanide poisoning

Interventions

Intervention1: Injection Sodium alpha-ketoglutarate (AKG) in combination with Injection sodium thiosulphate (STS): Single dose treatment with 20 ml of 12.5% solution of sodium alpha-ketoglutarate inje

Sponsors

Defence Research and Development Organisation
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a) Suspected or confirmed victims of cyanide poisoning (isolated or mass casualties) b) Suspected or confirmed victims of fire smoke / attack / act of terrorism with moderate-to-severe symptoms, including comatose subjects c) Rescue workers exposed to suspected to have been exposed to cyanide gas d) Very sick / comatose / non-respondent patients can also be taken up e) Pregnancy no bar in very sick patients confirmed as having likely to be lethal cyanide poisoning f) Subjects where conventional anticyanide treatment has been given, or is being given concurrently, or will be given later on

Exclusion criteria

Exclusion criteria: a) Those suffering from any disease or taking any treatment interfering with the AKG levels or cyanide levels in blood b)Any medical / social condition which in view of the investigators is deleterious for the subject / successful conduction of the test c) Where conventional medical treatment is available and the medical team decides in favor of conventional treatment alone d) Patients having any contraindications like severe diabetes mellitus, renal disease, severe blood pressure abnormality e) Refusal by patients / relatives (in case the patient is a minor or is in coma) f) Patients who have any medical condition which in the judgment of the investigator may render them in appropriate for participation in the trial

Design outcomes

Primary

MeasureTime frame
Reduction in mortality and severity of morbidity attributable to cyanide poisoningTimepoint: At the discretion of treating physician at the site of accident with the primary aim of reversal of clinical effects of cyanide poisoning in patients receiving AKG â?? thiosulphate combination therapy in comparison to those who received thiosulphate alone.

Secondary

MeasureTime frame
Reduction in cyanide induced toxicity symptoms with respect to parameters mentioned below:Timepoint: At the discretion of the treating physician at the field level.

Countries

India

Contacts

Public ContactAseem Bhatnagar

Defence Research and Development Organisation

dr.aseembhatnagar@gmail.com23905172

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026