MedPath

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).

Phase 3
Conditions
Health Condition 1: A419- Sepsis, unspecified organism
Registration Number
CTRI/2021/11/038268
Lead Sponsor
AIIMS NEW DELHI
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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)

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 immunosuppressantââ?¬•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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1.Inotrope free survival (Cessation of vasopressor)Timepoint: Hours to 10 days
Secondary Outcome Measures
NameTimeMethod
1. Reduction in Sequential Organ Failure Assessment (SOFA) Score <br/ ><br>2. Duration of hospital stay <br/ ><br>3. Duration of ICU stay <br/ ><br>4. Mortality <br/ ><br>Timepoint: 1. 0 to 24 <br/ ><br>2. 1 to 30 days <br/ ><br>3. 1 to 30 days <br/ ><br>4. 1 to 30 days
© Copyright 2025. All Rights Reserved by MedPath