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).
- 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
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
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
Name Time Method 1.Inotrope free survival (Cessation of vasopressor)Timepoint: Hours to 10 days
- Secondary Outcome Measures
Name Time Method 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