Skip to content

Effect of vitamin B1on septic shock patiens

Effectiveness of initial administration of thiamine in patients with septic shock in patients admitted in the adult intensive care unit

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190602043787N2
Enrollment
70
Registered
2020-07-07
Start date
2020-02-20
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic shock. Severe sepsis with septic shock

Interventions

Intervention 1: Intervention group: These patients are given two 100 miligram Vitamin B1 pills that each contains 100 miligram Vitamin B1 and manufactured by Daroopakhsh/Iran, twice daily for 7 days p

Sponsors

Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Ages over 18 years old Patients with septic shock(a patient that meets the criteria for sepsis and despite adequite fluid thrapy needs vasopressor to preserve MAP = 65mmhg and serum lactate is greater than 2 mmol) Complete informed consent form in the first stage of legal guardianship and in case of failure we refer to the judge of the country Serum lactate is greater than 2 mmol/li Hypotention(systolic BP less than 90 mmhg despite adequite fluid thrapy needs vasopressor(Dopamin = 5mcg/kg/min or Phenylephrine) Refusal to participate in any other intervention research project

Exclusion criteria

Exclusion criteria: Liver failure or dysfunction(AST OR ALT >240 unit/li or known cirrhosis) based on previous findings that patients with liver dysfunction may have increased levels of thiamine. Indication of receiving thiamine(Alcohol abuse) Other causes of increased lactate levels(seizure in 3 hours) Prescription of high-levev lactate -like drugs (Linezolid-Methformine)by your phicision Cyanide or CO poisoning Known mitochondrial disease Known or suspected ischemia of the intestine or other organs

Design outcomes

Primary

MeasureTime frame
Mortality within hospitalization. Timepoint: 28-day hospital mortality rate. Method of measurement: Patient mortality rate.;Duration of hospitalization in Intensive Care Unit. Timepoint: From the begining to the end of admition in Intensive Care Unit. Method of measurement: Number of days.;Level of serum lactate. Timepoint: At 0 and 24 hours after intervention. Method of measurement: By examining blood plasma by the method of euthoanalyzer.;Level of serum thiamine. Timepoint: At 0 hours after intervention. Method of measurement: High-performance liquid Chromatography(HOLC) with normal reference range 16-48 ng/ml.;Illness severity. Timepoint: Information on the Acute physiology and cronic health evaluation (APACHE II) questionnaire is collected once a week and Sequential organ failure assessment ( SOFA) questionnaire is collected every other day. Method of measurement: By index Sequential organ failure assessment ( SOFA) and Acute physiology and cronic health evaluation (APACHE II ) questionnaire.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Ataee

Mashhad University of Medical Sciences

ataeez@mums.ac.ir009838543031

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026