Thiamine As An Adjuvant Therapy For Hyperlactatemia In Septic Shock Patients

NCT03649009 | Unknown

• 1 other identifier: FF-2017-389
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Thiamine; Lactate; Septic shock

Outcome Measures

Primary Outcomes (1)

• Assessment of the relative lactate level change over 24 hours

  To assess the relative lactate level change from baseline to 24 hours after the initiation of the study drugs (defined as (lactate at 0 hour-lactate at 24 hours)/lactate at 0 hour x100%). Arterial blood sample for lactate will be collected in a heparinised blood-gas syringe by trained ICU staff nurse at enrolment (time 0) before commencing study drug, and 24 hours after the study drug administration. A blood lactate sample will be analyzed by using a blood gas analyzer in ICU (ABL 800 Basic, Radiometer Medical ApS, Denmark).

  0 -24 hours during the study drug administration

Secondary Outcomes (5)

• Assessment of the time for shock reversal

  From the date of randomization until the date of first documented weaning off the inotropes or date of death from any cause, whichever came first, assessed up to 100 weeks

• Assessment of the disease severity

  0- 24 hours after recruitment and randomization

• Assessment of patients' length of stay

  From the date of randomization until the date of either discharged from ICU or death from any cause, whichever came first, assessed up to 100 weeks.

• Assessment of the disease severity

  0 - 72 hours after recruitment and randomization

• Assessment of the rate of the lactate change over 72 hours

  0-72 hours during the study drug administration

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Normal Saline 50 mls infused over 1 hour 3 times per day for total 3 days for placebo group after recruitment and randomization done. If patients develop rashes or redness after normal saline administration, IV hydrocortisone (corticosteroid) 200mg stat dose will be given.

Other: Normal Saline; Drug: Hydrocortisone

IV Thiamine

ACTIVE COMPARATOR

IV Thiamine 200mg diluted in 50mls normal saline infused over 1 hour 3 times per day for total 3 days for Thiamine group after recruitment and randomization done. If patients develop nausea after thiamine administration, IV metoclopramide (antiemetic)10mg stat dose will be given. If patients develop redness and rashes after Normal Saline infusion, IV hydrocortisone (corticosteroid) 200mg stat dose will be given.

Drug: Thiamine; Drug: Hydrocortisone; Other: Metoclopramide

Interventions

Normal Saline OTHER

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

Normal Saline

Thiamine DRUG

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

Also known as: Vitamin B1

IV Thiamine

Hydrocortisone DRUG

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

Also known as: Corticosteroid

IV Thiamine; Normal Saline

Metoclopramide OTHER

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.

Also known as: Maxolon

IV Thiamine

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old
• Septic shock patients 16 (Definition: Sepsis( presence of two or more q Sequential Organ Failure Assessment with documented/suspected infection) and hypotension requiring use of vasopressors to maintain MAP≥ 65 mmHg and having serum lactate ≥ 2 mmol/L despite adequate fluid resuscitation (\> 30mls/kg of crystalloid within the first 3 hours)

You may not qualify if:

• Patients with a known allergy to the study drug.
• Pregnant patients
• Patients with limitation of therapy
• Patients with liver failure (include acute liver failure described as development of coagulopathy, international normalized ratio ( INR) of greater than 1.5, any degree of mental alteration( encephalopathy) in a patient without preexisting cirrhosis and with an illness of less than 26 weeks duration 17 or class C Child Pugh classification with the score of 10-15.18 )

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Hyperlactatemia; Shock, Septic

Interventions

Saline Solution; Thiamine; Hydrocortisone; Adrenal Cortex Hormones; Metoclopramide

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Shock

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Cheah SK DR, M. D.

  Universiti Kenangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheah SK DR, M.D

CONTACT

+60124859902; skii_cheah@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study is a single-blinded trial, with the participants from both intervention and placebo group will be masked
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a prospective, randomized controlled trial

Study Record Dates

• First Submitted: July 5, 2018
• First Posted: August 28, 2018
• Study Start: January 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 31, 2019
• Last Updated: August 31, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting from 3 month after publication
• Access Criteria: Share the information once approval from the publisher

Locations

MY (1)