To compare the results of two treatment protocol (standard treatment plus vitamin c, thiamine and hydrocortisone versus standard treatment plus hydrocortisone) used in surgical patients with septic shock (a/k/a infection in the body presenting with low blood pressure).

Metabolic resuscitation using early administration of ascorbic acid, thiamine and hydrocortisone in perioperative management of surgical patients with septic shock: A Randomized Controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038268

Enrollment

Registered

2021-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: A419- Sepsis, unspecified organism

Interventions

Intervention1: Group A: Standard treatment plus Hydrocortisone 100 mg IV bolus then 50 mg IV every 6th hourly for 10 days Ascorbic acid 1.5 gm. q 6th hourly for 10 days Thiamine 200Ã?Â mg q 12

Eligibility

Inclusion 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

Exclusion criteria: 1. Age 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 11. Alternate diagnosis causing shock e.g., myocardial infarction and severe congestive cardiac failure (NYHA class IV), pulmonary embolism, Child Pugh class C liver disease, patients on immunosuppressantÃ¢â?¬•s, chemotherapy / radiotherapy within 30 days prior to sepsis, haemorrhagic shock or GCS-3. 12. Pregnancy or breastfeeding 13. G6PD deficiency 14. Patients already on hydrocortisone, ascorbic acid and thiamine for reasons other than septic shock

Design outcomes

Primary

Measure	Time frame
1. Inotrope free survival (Cessation of vasopressor)Timepoint: Hours to 10 days	—

Secondary

Measure	Time frame
1. Reduction in Sequential Organ Failure Assessment (SOFA) Score 2. Duration of hospital stay 3. Duration of ICU stay 4. Mortality Timepoint: 1. 0 to 24 2. 1 to 30 days 3. 1 to 30 days 4. 1 to 30 days	—

Countries

India

Contacts

Public ContactManjunath Maruti Pol

All India Institute of Medical Sciences New Delhi

manjunath.pol@gmail.com09990187137

Outcome results

None listed

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