Supplemental Thiamine in Septic Shock: A Before-after Study

April 16, 2024 updated by: José Raimundo Araujo de Azevedo, Hospital Sao Domingos

Impact of Thiamine Supplementation on Clinical Outcomes of Patients With Septic Shock: a Retrospective Before-after Study

This controlled before-and-after study analyse the impact of thiamine supplementation on outcomes of patients with septic shock treated according to the surviving sepsis campaign 2021 guidelines

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Vitamin B1 (Thiamine) is a water-soluble vitamin that plays an important role in various biological processes. The active form is thiamine pyrophosphate, an essential cofactor in enzyme systems involved in carbohydrate metabolism and energy production. Recently, the role of thiamine in critically ill patients has gained prominence and septic shock has deserved special attention (1,2). It is important to emphasize that in these situations the clinical syndromes have low sensitivity and specificity for clinical diagnosis, which means that a high level of suspicion must be exercised in these situations. Donnino et al (3) analyzed 88 patients with septic shock in a prospective, randomized, double-blind study. The study showed that the administration of thiamine at a dose of 200 mg every 12 hours for 7 days had a significant impact on mortality only in patients who had reduced serum levels of thiamine. Woolum et al (4 ) retrospectively analyzed the impact of a single dose of Thiamine administered in the 24 hours that preceded the diagnosis of septic shock and compared with patients who did not receive the vitamin and identified improvement in lactate clearance and reduction in 28-day mortality in the thiamine group. Petsakul et al (5) evaluated the effect of thiamine administration in patients with septic shock and need for vasopressors and showed a significant reduction in the vasopressor dose in addition to improvement in lactate clearance. A recent meta-analysis including 5 studies and 645 patients with septic shock analyzed the impact of thiamine use on mortality. The study included 3 prospective randomized studies and 2 retrospective observational studies. The result showed a borderline beneficial effect on mortality. Regarding to HAT (Hydrocortisone, ascorbic acid and thiamine) therapy after the initial study by Marik et al. (7 ) at least 3 prospective randomized studies failed to repeat the good results of the initial study (8,9,10).

The sepsis management protocol at the São Domingos hospital underwent important changes from December 2021 to October 2022. In December, changes were incorporated in the protocol based on the new version of the Surviving Sepsis Campaign 2021 that had been launched the previous month ( 11). In April 2022 the SOSD (salvage, optimization, stabilization and de-resuscitation) systematics (12) was incoporated in the management of septic shock and in October 2022 thiamine use was implemented. Thiamine was incorporated into the protocol, although there are still no robust studies to indicate its use because, despite the implementation of previous measures with exceptional results in sepsis, between January and September 2022, mortality from sepsis was 1.69%, in the septic shock we had evolved little or nothing with mortality in the same period of 70%. In October, thiamine was started in isolated cases and as of November 2022, the investigators started using thiamine systematically and in all cases of septic shock at a dose of 200 mg EV every 12 hours for 7 days. In this controlled before-and-after study, the investigators compared outcomes of patients treated for septic shock between November 2022 and March 2023 with patients diagnosed with septic shock treated between May and September 2022.

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • MA
      • Sao Luis, MA, Brazil, 65060-000
        • Hospital São Domingos
    • Maranhão
      • São Luís, Maranhão, Brazil, 65060645
        • Hospital São Domingos

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This is a retrospective before-after study. Included were all patients with inclusion criteria admitted to a 13-bed surgical ICU, a 12-bed medical and a 12-bed high-complexity surgical and trauma ICU .during the 2 study periods: May 1 to September 30, 2022, control group and November 1, 2022 to March 31, 2023, study group.

Description

Inclusion Criteria:

  • age > 18 years
  • presence of documented or suspected infection, SOFA score ≥ 2, serum lactate levels > 18 mg/dL and hypotension, MAP < 65 mm Hg maintained after volume expansion of at least 30 ml/kg in the first 2 hours of treatment followed by noradrenaline vasopressor dependence (with or without vasopressin) during the first 6 hours of treatment.

Exclusion Criteria:

  • pregnant women
  • patients treated only with comfort measures.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Septic shock patients treated according surviving sepsis campaign 2021 guidelines
Intervention group
Septic shock patients treated according surviving sepsis campaign 2021 guidelines supplemented with thiamin 200 mg in 50 ml 5% dextrose twice daily for 7 days.
Drug: Thiamin
Patients in thiamine group received two daily dosis of 200 mg of thiamin diluted in 50 ml of 5% dextrose during 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare lactate clearance between intervention (thiamine supplemented) and control group.
Time Frame: 30 days
Lactate clearance defined as a consistent serum lactate level below 19 mg/dL after the start of treatment for septic shock
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of vasopressor-free days during ICU stay between the groups intervention and control
Time Frame: 30 days
Compare the vasopressor-free days between the two groups during the ICU stay
30 days
Comparison of vantilation-free days during ICU stay between the groups intervention and control
Time Frame: 30 days
Compare ventilation-free days between the two groups during the ICU stay
30 days
Compare the use of renal replacement therapy, n (%), initiated after 48 hours of septic shock between the groups intervention (thiamine supplementation) and control group
Time Frame: 30 days
- Compare the use of renal replacement therapy initiated after 48 hours of septic shock between the two groups.
30 days
Comparison of mortality rate between intervention (thiamine supplemented) and control
Time Frame: 30 days
To determine the mortality rate of patients with septic shock who received thiamine supplementation 200 mg twice daily for 7 days (intervention group) compared to a group that did not receive thiamine. Both groups treated according to Surviving Sepsis Campaign guidelines version 2021.
30 days

Collaborators and Investigators

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

Sponsor

Hospital Sao Domingos

Investigators

  • Principal Investigator: ISNARA S CARVALHO, RN, Hospital São Domingos

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)

September 1, 2023

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

April 30, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13/2023

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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