Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Drug: vitamin C, vitamin B1; Drug: vitamin B1

• Registration Number: NCT04137276
• Lead Sponsor: Indonesia University

Brief Summary

This study aimed to explore the effect of intravenous (IV) vitamin C on sequential organ failure assessment (SOFA) score among septic patients in intensive care unit (ICU).

Detailed Description

"This study was approved by the Ethics and Research Committee of Universitas Indonesia. This study was a randomized clinical trial held from April to July 2019 in Cipto Mangunkusumo Hospital. 33 patients that met the inclusion criteria were included in the study. Subjects were divided into two groups: group A (intervention group, n = 18) received parenteral infusions of 1,5 g/6 hours of vitamin C and 200 mg thiamine, while group B (control group, n = 15) received 200 mg thiamine only. baseline demographic data was recorded on the first day. SOFA score was recorded at baseline, 24 hours, 48 hours, and 72 hours after treatment. Data were analyzed using SPSS (Statistical Package for Social Sciences) software."

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-30
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• patients with sepsis diagnosis based on sepsis-3 criteria in the ICU in between 6 hours to 24 hours post resuscitation after sepsis diagnosis

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Exclusion Criteria

• patients with chronic kidney problems on haemodialysis,
• patients with kidney stones or kidney problem within the last 3 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vitamin C and thiamine	vitamin C, vitamin B1	patients who received intravenous vitamin C and thiamine
thiamine	vitamin B1	patients who received thiamine

Primary Outcome Measures

Name	Time	Method
Sequential Organ Failure Assessment (SOFA) score	3 months	Sequential Organ Failure Assessment (SOFA) score score measured at several specified times. higher score indicates higher mortality in septic patients.

Trial Locations

Locations (1)

Cipto Mangunkusumo General Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia