NCT06224881

Brief Summary

Objectives: investigators aim to study the effect of addition of vitamin C as a part of treatment in septic shock patients on: Hemodynamics, Inflammation status and ICU outcome. Subjects and methods: A prospective interventional randomized cohort study, was conducted on 150 consecutive patients who were admitted to the ICU with septic shock based on SIRS, SOFA and APACHE II. Treatment group (n=75) had given ascorbic acid (Vitamin C) parenterally 6gm daily and control group (n=75). Measuring the level of Vitamin C in all study population (normal range 50-70 μM/L) before and after period of 4 days.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

1.2 years

First QC Date

December 28, 2023

Last Update Submit

January 24, 2024

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (2)

  • C-reactive protein

    C-reactive protein level III- Vasopressor (noradrenaline) dose and duration

    Evaluated on a daily basis for 4 days

  • Mean arterial blood pressure

    Mean arterial blood pressure (MAP).

    Evaluated on a daily basis for 4 days

Secondary Outcomes (2)

  • ICU Length of stay . II- 7 day mortality rate. III- 28 days mortality

    28 days

  • ICU mortality

    28 days

Study Arms (2)

Vitamin C group

ACTIVE COMPARATOR

Ascorbic acid (Vitamin C) was given parenterally (2 gm every 8hrs) for 4 days.

Drug: Ascorbic acid

Control group

PLACEBO COMPARATOR

No vit C given

Drug: Ascorbic acid

Interventions

Ascorbic acidDRUG

2 gm every 8hrs for 4 days

Control groupVitamin C group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Septic shock (defined by sepsis induced hypotension i.e. MAP \< 65 mmHg, tissue hypo-perfusion, vasopressors

You may not qualify if:

  • Age below 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo university

Cairo, 11345, Egypt

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Mohamed Ashraf, MD

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of critical care

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 25, 2024

Study Start

December 1, 2021

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)