Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT04137276

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Drug: vitamin C, vitamin B1 Drug: vitamin B1	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

33 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Effect of Intravenous Vitamin C on Sequential Organ Failure Assessment (SOFA) Score Among Septic Patients: Randomized Controlled Trial

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: vitamin C and thiamine patients who received intravenous vitamin C and thiamine	Drug: vitamin C, vitamin B1 vitamin C 1,5 g/6 hours IV + thiamine 200 mg/12 hours for 3 days Other Names: group A
Active Comparator: thiamine patients who received thiamine	Drug: vitamin B1 thiamine 200 mg/12 hours for 3 days Other Names: group B

Arm

Intervention/Treatment

Experimental: vitamin C and thiamine

patients who received intravenous vitamin C and thiamine

Drug: vitamin C, vitamin B1

vitamin C 1,5 g/6 hours IV + thiamine 200 mg/12 hours for 3 days

Other Names:

group A

Active Comparator: thiamine

patients who received thiamine

Drug: vitamin B1

thiamine 200 mg/12 hours for 3 days

Other Names:

group B

Outcome Measures

Primary Outcome Measures

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.