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Thiamine As An Adjuvant Therapy For Hyperlactatemia In Septic Shock Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03649009
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Universiti Kebangsaan Malaysia Medical Centre

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.

Condition or disease Intervention/treatment Phase
Hyperlactatemia Other: Normal Saline Drug: Thiamine Drug: Hydrocortisone Other: Metoclopramide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a prospective, randomized controlled trial
Masking: Single (Participant)
Masking Description: This study is a single-blinded trial, with the participants from both intervention and placebo group will be masked
Primary Purpose: Prevention
Official Title: Thiamine As An Adjuvant Therapy For Hyperlactatemia In Septic Shock Patients: A Prospective Randomized Study
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Placebo Comparator: Normal Saline

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
Normal Saline 50 mls 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 Name: Corticosteroid

Active Comparator: IV Thiamine

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
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
Other Name: Vitamin B1

Drug: Hydrocortisone
If patient develop redness or rashes after normal saline infusion, IV hydrocortisone 200 mg stat will be given
Other Name: Corticosteroid

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.
Other Name: Maxolon




Primary Outcome Measures :
  1. Assessment of the relative lactate level change over 24 hours [ Time Frame: 0 -24 hours during the study drug administration ]

    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).



Secondary Outcome Measures :
  1. Assessment of the time for shock reversal [ Time Frame: 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 duration used for weaning off the vasopressors in hours. It will be calculated from the date and time of the inotropes started until the date and time of the inotropes stopped

  2. Assessment of the disease severity [ Time Frame: 0- 24 hours after recruitment and randomization ]
    To assess APACHE (Acute physiology and Chronic Health Evaluation) II score to predict the patient mortality. APACHE II score consists of 12 variables with maximum score of 72. The higher the score, the higher the risk of patient's mortality.

  3. Assessment of patients' length of stay [ Time Frame: 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. ]
    After patient was recruited, patient will be assessed the total length of stay in ICU in terms of days

  4. Assessment of the disease severity [ Time Frame: 0 - 72 hours after recruitment and randomization ]

    To assess SOFA (sequential organ failure assessment) score to predict patient's mortality risk. The higher the score, the higher the mortality risk.

    SOFA score is based of the degree of 6 organ dysfunction with maximum score of 24.

    Assessment will recorded from the time 0 (after recruitment and randomization) and at 24 hours, 48 hours, and 72 hours.


  5. Assessment of the rate of the lactate change over 72 hours [ Time Frame: 0-72 hours during the study drug administration ]
    To assess the rate of the lactate change over 72 hours after study drug administration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years old
  2. 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)

Exclusion Criteria:

  1. Patients with a known allergy to the study drug.
  2. Pregnant patients
  3. Patients with limitation of therapy
  4. 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 )

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649009


Contacts
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Contact: Cheah SK DR, M.D +60124859902 skii_cheah@yahoo.com

Locations
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Malaysia
Universiti Kebangsaan Malaysia Medical Centre Recruiting
Cheras, Kuala Lumpur, Malaysia, 56000
Contact: Cheah SK Dr, M.D.         
Sponsors and Collaborators
Universiti Kebangsaan Malaysia Medical Centre
Investigators
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Principal Investigator: Cheah SK DR, M. D. Universiti Kenangsaan Malaysia Medical Centre

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Responsible Party: Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT03649009    
Other Study ID Numbers: FF-2017-389
First Posted: August 28, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Starting from 3 month after publication
Access Criteria: Share the information once approval from the publisher

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Universiti Kebangsaan Malaysia Medical Centre:
Thiamine
Lactate
Septic shock
Additional relevant MeSH terms:
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Shock, Septic
Hyperlactatemia
Shock
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Metabolic Diseases
Signs and Symptoms
Thiamine
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Metoclopramide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients