CTRI/2021/11/038268
Recruiting
Phase 3
Metabolic resuscitation using early administration of ascorbic acid, thiamine and hydrocortisone in perioperative management of surgical patients with septic shock: A Randomized Controlled trial
AIIMS NEW DELHI0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: A419- Sepsis, unspecified organism
- Sponsor
- AIIMS NEW DELHI
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Perioperative septic shock: peritonitis due to hollow viscus perforation, ruptured solid organ abscess, pyoperitoneum, intestinal obstruction.
- •2\. Controlled source of infection: Post\-intervention (surgical or non\-surgical) control of source of infection
- •3\. 18 to 70 years, both gender
- •4\. Ready to participate in the study
Exclusion Criteria
- •1\. Age \< 18 years and \> 70 years
- •2\. Refusal to consent and DNR orders (patient or patients family do not consent for the resuscitation and study)
- •3\. Septic shock for \> 24 hours
- •4\. Failure to administer intervention drugs within 6 hours of presentation of septic shock
- •5\. Proven active COVID\-19 infection, HIV infection, known immunodeficiency diseases
- •6\. Allergy to either of the intervention drugs (allergy to ascorbic acid or thiamine or hydrocortisone)
- •7\. Uncontrollable source of infection e.g., Unresectable dead bowel,
- •8\. Recurrent, unresectable or metastatic cancer
- •9\. Patient on antifungal infection for systemic fungal infection
- •10\. Imminent death or Inevitable deaths: metastatic cancer or haematological malignancy, more than four failed organs at entry (or multiorgan dysfunction syndrome), APACHE II score \> 30 at presentation, granulocytopenia leucocyte count \< 500cells/ml and/or thrombocytopenia \< 30000 cells/ml)
Outcomes
Primary Outcomes
Not specified
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