Triple Therapy in Septic Shock Patients

NCT04508946 | Completed Phase 3

• 1 other identifier: 2019/11
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Septic Shock; Sepsis; Organ Dysfunction Syndrome Sepsis

Keywords

Septic shock; Vitamin C; Thiamine; Hydrocortisone; sepsis

Outcome Measures

Primary Outcomes (2)

• The number of patients who died within 28 days.

  patients were followed up daily for 28 days, this is the number of patients who died within 28 days.

  28 days

• ICU Mortality

  The number of patients who died during ICU stay

  Within 28 days

Secondary Outcomes (3)

• the number of days that are needed to off the patients from vasopressors.

  28 Days

• the number of days that are needed to off the patients from mechanical ventilation.

  28 days

• Change in organ's functions test such as (serum creatinine, Alanine Aminotransferase (ALT)

  28 days

Study Arms (2)

Hydrocortisone Monotherapy

ACTIVE COMPARATOR

Hydrocortisone Monotherapy

Drug: vitamin c - thiamine- hydrocortisone

triple therapy regimen (vitamin c - thiamine- hydrocortisone)

EXPERIMENTAL

triple therapy regimen (vitamin c - thiamine- hydrocortisone)

Drug: vitamin c - thiamine- hydrocortisone

Interventions

vitamin c - thiamine- hydrocortisone DRUG

Triple therapy regimen (vitamin c - thiamine- hydrocortisone)

Also known as: Triple therapy

Hydrocortisone Monotherapy; triple therapy regimen (vitamin c - thiamine- hydrocortisone)

Eligibility Criteria

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

You may qualify if:

• Age \>18 years.
• Diagnosis of septic shock has been established (need vasopressors to maintain MAP ≥ 65, lactate ≥ 2mmol/L and SOFA score ≥2) \[25,26\].

You may not qualify if:

• 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

Sponsors & Collaborators

• Air Force Specialized Hospital, Cairo, Egypt: lead

Study Sites (1)

Air Force Specialized Hospital

Cairo, 4260010, Egypt

Location

Related Publications (5)

• Dellinger RP, Levy MM, Rhodes A, Annane D, Gerlach H, Opal SM, Sevransky JE, Sprung CL, Douglas IS, Jaeschke R, Osborn TM, Nunnally ME, Townsend SR, Reinhart K, Kleinpell RM, Angus DC, Deutschman CS, Machado FR, Rubenfeld GD, Webb SA, Beale RJ, Vincent JL, Moreno R; Surviving Sepsis Campaign Guidelines Committee including the Pediatric Subgroup. Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.

  PMID: 23353941 RESULT

• Plevin R, Callcut R. Update in sepsis guidelines: what is really new? Trauma Surg Acute Care Open. 2017 Sep 7;2(1):e000088. doi: 10.1136/tsaco-2017-000088. eCollection 2017.

  PMID: 29766091 RESULT

• Korosec Jagodic H, Jagodic K, Podbregar M. Long-term outcome and quality of life of patients treated in surgical intensive care: a comparison between sepsis and trauma. Crit Care. 2006;10(5):R134. doi: 10.1186/cc5047.

  PMID: 16978417 RESULT

• Zahar JR, Timsit JF, Garrouste-Orgeas M, Francais A, Vesin A, Descorps-Declere A, Dubois Y, Souweine B, Haouache H, Goldgran-Toledano D, Allaouchiche B, Azoulay E, Adrie C. Outcomes in severe sepsis and patients with septic shock: pathogen species and infection sites are not associated with mortality. Crit Care Med. 2011 Aug;39(8):1886-95. doi: 10.1097/CCM.0b013e31821b827c.

  PMID: 21516036 RESULT

• Angus DC, van der Poll T. Severe sepsis and septic shock. N Engl J Med. 2013 Aug 29;369(9):840-51. doi: 10.1056/NEJMra1208623. No abstract available.

  PMID: 23984731 RESULT

MeSH Terms

Conditions

Shock, Septic; Sepsis; Toxemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Abdelrhman Hussein

  Air Force Specialized Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2020
• First Posted: August 11, 2020
• Study Start: August 1, 2019
• Primary Completion: November 9, 2020
• Study Completion: November 9, 2020
• Last Updated: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)