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Thiamine As An Adjuvant Therapy For Hyperlactatemia In Septic Shock Patients

NCT03649009 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2018-08-31

No results posted yet for this study

Summary

The study aimed to assess the effectiveness of intravenous thiamine as compared with placebo in reducing the lactate level in septic shock patients.

Conditions

  • Hyperlactatemia

Interventions

OTHER

Normal Saline

Normal Saline 50 mls infused over 1 hour 3 times per day for total 3 days after recruitment and randomization.

DRUG

Thiamine

IV Thiamine 200 mg diluted in 50 mls normal saline infused over 1 hour 3 times per day for total 3 days after recruitment and randomization

DRUG

Hydrocortisone

If patient develop redness or rashes after normal saline infusion, IV hydrocortisone 200 mg stat will be given

OTHER

Metoclopramide

If patient develop nausea after IV thiamine infusion, IV metoclopramide 10mg stat will be given. If patient develop redness or rashes after normal saline infusion, IV hydrocortisone 200 mg stat will be given.

Sponsors & Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

    lead OTHER

Principal Investigators

  • Cheah SK DR, M. D. · Universiti Kenangsaan Malaysia Medical Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2018-12-01
Completion
2019-03-31

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03649009 on ClinicalTrials.gov