Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

NCT ID: NCT04137276

Last Updated: 2020-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2019-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

"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."

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

vitamin C and thiamine

patients who received intravenous vitamin C and thiamine

Group Type EXPERIMENTAL

vitamin C, vitamin B1

Intervention Type DRUG

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

thiamine

patients who received thiamine

Group Type ACTIVE_COMPARATOR

vitamin B1

Intervention Type DRUG

thiamine 200 mg/12 hours for 3 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vitamin C, vitamin B1

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

Intervention Type DRUG

vitamin B1

thiamine 200 mg/12 hours for 3 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

group A group B

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adhrie Sugiarto

Staff Lecturer at Department of Anesthesiology and Intensive Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Adhrie Sugiarto

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Indonesia

References

Explore related publications, articles, or registry entries linked to this study.

Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

Reference Type RESULT
PMID: 26903338 (View on PubMed)

Carr AC, Shaw GM, Fowler AA, Natarajan R. Ascorbate-dependent vasopressor synthesis: a rationale for vitamin C administration in severe sepsis and septic shock? Crit Care. 2015 Nov 27;19:418. doi: 10.1186/s13054-015-1131-2.

Reference Type RESULT
PMID: 26612352 (View on PubMed)

Bagshaw SM, George C, Bellomo R; ANZICS Database Management Committee. Early acute kidney injury and sepsis: a multicentre evaluation. Crit Care. 2008;12(2):R47. doi: 10.1186/cc6863. Epub 2008 Apr 10.

Reference Type RESULT
PMID: 18402655 (View on PubMed)

Bellomo R, Kellum JA, Ronco C, Wald R, Martensson J, Maiden M, Bagshaw SM, Glassford NJ, Lankadeva Y, Vaara ST, Schneider A. Acute kidney injury in sepsis. Intensive Care Med. 2017 Jun;43(6):816-828. doi: 10.1007/s00134-017-4755-7. Epub 2017 Mar 31.

Reference Type RESULT
PMID: 28364303 (View on PubMed)

Heyland D, Muscedere J, Wischmeyer PE, Cook D, Jones G, Albert M, Elke G, Berger MM, Day AG; Canadian Critical Care Trials Group. A randomized trial of glutamine and antioxidants in critically ill patients. N Engl J Med. 2013 Apr 18;368(16):1489-97. doi: 10.1056/NEJMoa1212722.

Reference Type RESULT
PMID: 23594003 (View on PubMed)

Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.

Reference Type RESULT
PMID: 27940189 (View on PubMed)

Oudemans-van Straaten HM, Elbers PWG, Spoelstra-de Man AME. How to Give Vitamin C a Cautious but Fair Chance in Severe Sepsis. Chest. 2017 Jun;151(6):1199-1200. doi: 10.1016/j.chest.2017.01.008. Epub 2017 Apr 7. No abstract available.

Reference Type RESULT
PMID: 28599924 (View on PubMed)

Moskowitz A, Andersen LW, Cocchi MN, Karlsson M, Patel PV, Donnino MW. Thiamine as a Renal Protective Agent in Septic Shock. A Secondary Analysis of a Randomized, Double-Blind, Placebo-controlled Trial. Ann Am Thorac Soc. 2017 May;14(5):737-741. doi: 10.1513/AnnalsATS.201608-656BC.

Reference Type RESULT
PMID: 28207287 (View on PubMed)

Abiles J, de la Cruz AP, Castano J, Rodriguez-Elvira M, Aguayo E, Moreno-Torres R, Llopis J, Aranda P, Arguelles S, Ayala A, de la Quintana AM, Planells EM. Oxidative stress is increased in critically ill patients according to antioxidant vitamins intake, independent of severity: a cohort study. Crit Care. 2006;10(5):R146. doi: 10.1186/cc5068.

Reference Type RESULT
PMID: 17040563 (View on PubMed)

Galley HF, Howdle PD, Walker BE, Webster NR. The effects of intravenous antioxidants in patients with septic shock. Free Radic Biol Med. 1997;23(5):768-74. doi: 10.1016/s0891-5849(97)00059-2.

Reference Type RESULT
PMID: 9296454 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IndonesiaUAnes 39

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Vitamin C and Septic Shock
NCT03338569 COMPLETED PHASE2/PHASE3