Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

NCT04137276 | Completed

• 1 other identifier: IndonesiaUAnes 39
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis

Keywords

sepsis; intravenous vitamin C; SOFA score

Outcome Measures

Primary Outcomes (1)

• Sequential Organ Failure Assessment (SOFA) score

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

  3 months

Study Arms (2)

vitamin C and thiamine

EXPERIMENTAL

patients who received intravenous vitamin C and thiamine

Drug: vitamin C, vitamin B1

thiamine

ACTIVE COMPARATOR

patients who received thiamine

Drug: vitamin B1

Interventions

vitamin C, vitamin B1 DRUG

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

Also known as: group A

vitamin C and thiamine

vitamin B1 DRUG

thiamine 200 mg/12 hours for 3 days

Also known as: group B

thiamine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (10)

• 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.

  PMID: 26903338 RESULT

• 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.

  PMID: 26612352 RESULT

• 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.

  PMID: 18402655 RESULT

• 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.

  PMID: 28364303 RESULT

• 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.

  PMID: 23594003 RESULT

• 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.

  PMID: 27940189 RESULT

• 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.

  PMID: 28599924 RESULT

• 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.

  PMID: 28207287 RESULT

• 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.

  PMID: 17040563 RESULT

• 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.

  PMID: 9296454 RESULT

MeSH Terms

Conditions

Sepsis

Interventions

Ascorbic Acid; Thiamine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Adhrie Sugiarto

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Lecturer at Department of Anesthesiology and Intensive Care

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: April 1, 2019
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)