Triple Therapy in Septic Shock Patients

• Status: Completed
• Trial end date: 2020-11-09
• Target enrollment: 0
• Participant gender: All

Summary

this study is conducted to evaluate the role of the novel triple therapy combination in reducing the mortality rate, reducing the shock time, and reversal of organ damage.

the study includes two arms, the first arm is the control which received hydrocortisone monotherapy and the second arm is the intervention arm which received the triple therapy regimen.

calculation of 28 days in-hospital mortality is the primary outcome. shock time, vasopressor doses, infection markers, and organ function tests are the secondary outcomes.

the data will be analyzed by student t-test or Mann Whitney test, Fischer exact or chi-square test for numbers, repeated measures ANOVA will be used to consider confounders and other parameters, mortality will be expressed by Kaplan Meier and ROC curve.

For Multivariate analysis of repeated quantitative outcomes, linear mixed models were used to quantify the relationship between one dependent variable (SOFA, SCr, doses of vasopressors) and many independent variables including group type and sepsis phenotype adjusted to other clinical and demographic factors.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Air Force Specialized Hospital, Cairo, Egypt
• Treatments: Ascorbic Acid; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Thiamine

Criteria

Inclusion Criteria:

• Age >18 years.

• Diagnosis of septic shock has been established (need vasopressors to maintain MAP ≥ 65, lactate ≥ 2mmol/L and SOFA score ≥2) [25,26].

Exclusion Criteria:

• Pregnancy and lactation.

• Refusal of attending staff or patient family.

• Contraindication to any of the components of the triple therapy regimen such as (hypersensitivity to vitamin C and Patients with G6PD deficiency).

• Patients on immunosuppressive medications and oncology patients. Do not resuscitate/do not intubate (DNR, DNI) patients