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

NCT04160676 | Completed

• 1 other identifier: 33375/09/19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hydrocortison; Ascorbic acid; Thiamine

Outcome Measures

Primary Outcomes (1)

• 28th day mortality rate.

  The incidence of mortality in the first 28 days

  28 days

Secondary Outcomes (2)

• Changes in SOFA score

  28 days

• Changes in serum pocalcitonin level

  7 days

Study Arms (2)

Group I

ACTIVE COMPARATOR

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.

Drug: Normal saline

Group II

EXPERIMENTAL

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 This combined therapy will be given for 4 days or to the time of discharge if the admission period is less than 4 days

Drug: Hydrocortisone, Ascorbic acid, Thiamine

Interventions

Hydrocortisone, Ascorbic acid, Thiamine DRUG

Combination of hydrocortisone, ascorbic acid, and thiamine

Group II

Normal saline DRUG

Normal saline

Group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead
• Mostafa Ismail Sharaf: collaborator
• Salah Eldeen Ibrahim Alsherif: collaborator
• Mohamed Mohi El deen Abo El yazeed: collaborator

Study Sites (1)

Tanta University hospitals

Tanta, 31511, Egypt

Location

MeSH Terms

Conditions

Sepsis

Interventions

Hydrocortisone; Ascorbic Acid; Thiamine; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Sameh Ismaiel, M.D

  Lecturer of Anesthesia and Intensive Care, Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All data will be collected by intensivists who will be blinded about the study groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Parallel assignment Prospective study

Study Record Dates

• First Submitted: November 9, 2019
• First Posted: November 13, 2019
• Study Start: December 1, 2019
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: August 2, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)