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Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

Primary Purpose

Sepsis

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
vitamin C, vitamin B1
vitamin B1
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sepsis focused on measuring sepsis, intravenous vitamin C, SOFA score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cipto Mangunkusumo General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

vitamin C and thiamine

thiamine

Arm Description

patients who received intravenous vitamin C and thiamine

patients who received thiamine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 22, 2019
Last Updated
December 30, 2019
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT04137276
Brief Title
Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients
Official Title
Effect of Intravenous Vitamin C on Sequential Organ Failure Assessment (SOFA) Score Among Septic Patients: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
sepsis, intravenous vitamin C, SOFA score

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
vitamin C and thiamine
Arm Type
Experimental
Arm Description
patients who received intravenous vitamin C and thiamine
Arm Title
thiamine
Arm Type
Active Comparator
Arm Description
patients who received thiamine
Intervention Type
Drug
Intervention Name(s)
vitamin C, vitamin B1
Other Intervention Name(s)
group A
Intervention Description
vitamin C 1,5 g/6 hours IV + thiamine 200 mg/12 hours for 3 days
Intervention Type
Drug
Intervention Name(s)
vitamin B1
Other Intervention Name(s)
group B
Intervention Description
thiamine 200 mg/12 hours for 3 days
Primary Outcome Measure Information:
Title
Sequential Organ Failure Assessment (SOFA) score
Description
Sequential Organ Failure Assessment (SOFA) score score measured at several specified times. higher score indicates higher mortality in septic patients.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adhrie Sugiarto
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo General Hospital
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26903338
Citation
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.
Results Reference
result
PubMed Identifier
26612352
Citation
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.
Results Reference
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PubMed Identifier
18402655
Citation
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.
Results Reference
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PubMed Identifier
28364303
Citation
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.
Results Reference
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PubMed Identifier
23594003
Citation
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. Erratum In: N Engl J Med. 2013 May 9;368(19):1853. Dosage error in article text.
Results Reference
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PubMed Identifier
27940189
Citation
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.
Results Reference
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PubMed Identifier
28599924
Citation
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.
Results Reference
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PubMed Identifier
28207287
Citation
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.
Results Reference
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PubMed Identifier
17040563
Citation
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.
Results Reference
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PubMed Identifier
9296454
Citation
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.
Results Reference
result

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Effect of Intravenous Vitamin C on SOFA Score Among Septic Patients

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