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

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.

Conditions

• Sepsis

Interventions

DRUG

Hydrocortisone, Ascorbic acid, Thiamine

Combination of hydrocortisone, ascorbic acid, and thiamine

DRUG

Normal saline

Normal saline

Sponsors & Collaborators

• Mostafa Ismail Sharaf

  collaborator UNKNOWN

• Salah Eldeen Ibrahim Alsherif

  collaborator UNKNOWN

• Mohamed Mohi El deen Abo El yazeed

  collaborator UNKNOWN

• Tanta University

  lead OTHER

Principal Investigators

• Sameh Ismaiel, M.D · Lecturer of Anesthesia and Intensive Care, Tanta University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-01

Primary Completion

2021-07-26

Completion

2021-07-26

Countries

• Egypt

Study Locations