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Clinical trial

Treating Vitamin C Deficiency in Septic Shock: Would it Help?

ID
Name
MS-362-2019
Description
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 arms
Trial start
2021-12-01
Estimated PCD
2023-01-31
Trial end
2023-01-31
Status
Completed
Phase
Early phase I
Treatment
Ascorbic acid
2 gm every 8hrs for 4 days
Arms:
Control group, Vitamin C group
Size
150
Primary endpoint
C-reactive protein
Evaluated on a daily basis for 4 days
Mean arterial blood pressure
Evaluated on a daily basis for 4 days
Eligibility criteria
Inclusion Criteria: * Septic shock (defined by sepsis induced hypotension i.e. MAP \< 65 mmHg, tissue hypo-perfusion, vasopressors Exclusion Criteria: * Age below 18 years old
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2024-01-25

1 organization

1 product

1 indication

Organization
Cairo University
Product
Ascorbic acid
Indication
Septic shock