Effect of test drugs (Hydrocortisone, Ascorbic acid, and Thiamine) in patients with septic shock.

Phase 3

• Conditions: Health Condition 1: O- Medical and Surgical

• Registration Number: CTRI/2023/11/059609
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 19 December 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Illness -Admitted to PICU treated for septic shock (fluid refractory shock)

Treatment Received inotropes for at least 2 h

Consent Parental/caregiver consent prior to or after enrolment

(Definitions of surviving sepsis campaign 2020 will be followed for diagnosis of septic shock)

Exclusion Criteria

1.Age Preterm babies born <34 weeks gestation that have a corrected age of <28 days

2.Treatment - Received inotropes for >24 h pre-enrolment

3.Patient is receiving treatment for a systemic fungal infection or has documented strongyloides infection at the time of randomization

4.Patient undergoing active chemotherapy for cancer treatment

5.Co-morbidities •Fulmonant Myocarditis, Congenital heart disease

6.Chronic hypertension due to cardiovascular or renal disease, requiring regular antihypertensive treatment.

7.Known chronic kidney disease (defined as requiring Renal Replacement Therapy)

8.Known chronic hepatic failure

9.Known diseases affecting the steroid axis, including pituitary disease, congenital adrenal hypoplasia, Cushing or Addison’s

a.disease

10.Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency

11.Patients with a known history of oxalate nephropathy

12.Patients with acute beriberi disease

13.Patients with acute Wernike’s encephalopathy

14.Patients with known malaria

15.Patients with known suspected scurvy

16.Palliative care patient/patient with limitation of treatment (not for inotropes, cardiopulmonary resuscitation, extracorporeal membrane oxygenation, intubation, or ventilation)

17.Cardiopulmonary arrest in the past 2 h requiring cardiopulmonary resuscitation of >2min duration, or death is deemed to be imminent or inevitable during this admission.

18.Major bleeding with hemorrhagic shock

19.Sepsis is not likely to be the cause of shock

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the total number of organ failure-free days in the first 28 daysTimepoint: First 28 days from the day of randomization

Secondary Outcome Measures

Name	Time	Method
1.Total duration of inotropes received in days. <br/ ><br>2.Change in the pSOFA score from time of randomization to 72 hours & at 28 days will be used to calculate organ dysfunction free days <br/ ><br>3.Day of admission to discharge <br/ ><br>4.Duration of PICU stay <br/ ><br>5.Time needed for resolution of acute kidney injury <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 28 days