Therapy With Hydrocortisone, Ascorbic Acid, Thamine in Patients With Sepsis

• Status: Completed
• Trial end date: 2021-07-26
• Target enrollment: 0
• Participant gender: All

Summary

In this study , we suggest that the use of combination of Hydrocortisone, Ascorbic Acid, and Thiamine in patient with sepsis may decrease mortality rate and improve the outcome.

This study will be carried out at SICU of Tanta University hospitals on Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016.

Patients who will meet the previous criteria will be enrolled in the study. The patients will be randomized allocated into two groups by the aid of computer generated software of randomization introduced into sealed closed envelops.

All patients will receive the conventional therapy according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update.

The patients will be allocated randomly into one of the following two groups;-. Group I The patients in this group will be managed only according to the surviving sepsis campaign 2016 and the surviving sepsis campaign bundle 2018 update.

The patients will receive 50 ml normal saline I.V within 30 mins / 6 h, 10 ml normal saline I.V / 6 h, 5 ml normal saline I.V / 12 h.

Group II The patients will receive the conventional therapy of sepsis and combined therapy of hydrocortisone (Solucortif® 100 mg , vial, dried powder Pfizer, Egypt) 50 mg diluted in 5 ml normal saline IV / 6 h, ascorbic acid (VITAMIN C-®, Amp, ROTEXMEDICA, Germany, 500mg/5ml) 1.5 gm diluted in 50 ml normal saline IV within 30 min /6 h , and thiamine (Vitamin B1-injektopas®, Ampoule, Germany, 100 mg / 2 ml) 200 mg diluted in 10 ml normal saline IV /12 h The outcome of the patients, the incidence of organ dysfunction will be assessed.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tanta University
• Collaborators: Mohamed Mohi El deen Abo El yazeed; Mostafa Ismail Sharaf; Salah Eldeen Ibrahim Alsherif
• Treatments: Ascorbic Acid; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Thiamine

Criteria

Inclusion Criteria:

• Patients aged from 18 to 65 years old who will be presented with sepsis that diagnosed according to the surviving sepsis campaign 2016 and The Surviving Sepsis Campaign Bundle 2018 Update

Exclusion Criteria:

• Participant or participants' relatives refusal to continue the study.

• Known or suspected allergy to the studied medications.

• Contraindications to the use of vitamin C as renal stones, Alzheimer's disease and Schizophrenia.

• Pre-existing organ failure or dysfunction not related to the presenting sepsis condition.

• Pregnancy.