Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

December 30, 2019 updated by: Adhrie Sugiarto, Indonesia University

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sequential Organ Failure Assessment (SOFA) score
Time Frame: 3 months
Sequential Organ Failure Assessment (SOFA) score score measured at several specified times. higher score indicates higher mortality in septic patients.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Adhrie Sugiarto, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

July 31, 2019

Study Completion (ACTUAL)

July 31, 2019

Study Registration Dates

First Submitted

October 22, 2019

First Submitted That Met QC Criteria

October 22, 2019

First Posted (ACTUAL)

October 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 30, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes 39

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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