NCT01070810

Brief Summary

The major goal of this project is to determine whether the use of thiamine in patients with septic shock will result in attenuation of lactic acidosis and a more rapid reversal of shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

May 15, 2017

Completed
Last Updated

May 15, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

February 17, 2010

Results QC Date

January 20, 2016

Last Update Submit

April 29, 2017

Conditions

Septic Shock

Keywords

Septic ShockSepsis

Outcome Measures

Primary Outcomes (1)

  • Lactate Level 24 Hours After the First Study Medication Dose

    24 hours

Secondary Outcomes (2)

  • Number of Participants With Shock Reversal

    Hospital stay, average 2 weeks

  • APACHE II Score at 24 Hours

    24 hours

Other Outcomes (2)

  • Lactate Level at 24 Hours in Patients With Baseline Thiamine Deficiency

    24 hours

  • Number of Participants Dying Before Hospital Discharge in Patients With Baseline Thiamine Deficiency

    Hospital stay, average 2 weeks

Study Arms (2)

1

PLACEBO COMPARATOR

50 ml D5W

Drug: D5W

2

EXPERIMENTAL

200mg Thiamine in 50ml D5W

Drug: Thiamine

Interventions

D5WDRUG

Dextrose 5%

1
ThiamineDRUG

Thiamine 200mg in 50ml D5W

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than 18 years old
  • Suspected or confirmed source of infection
  • Hypotension (systolic pressure \<90 mmHg) after a minimum 2 liter fluid bolus followed by vasopressor-dependence.
  • Lactic Acidosis \> 3 mmol/dl

You may not qualify if:

  • Competing cause of lactic acidosis including: seizures within 3 hours of enrollment, use of linazolid metformin or anti-retrovirals at the time of enrollment, carbon monoxide or cyanide poisoning, highly suspected or known ischemic bowel, and known mitochondrial disorders
  • Liver dysfunction specifically defined as AST or ALT elevation greater than 240
  • Current Thiamine supplements or usage
  • Competing indication for thiamine administration
  • Cardiac Arrest
  • DNR/DNI or comfort care status (DNR status in an intubated patient receiving full care is eligible)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Vine J, Lee JH, Kravitz MS, Grossestreuer AV, Balaji L, Leland SB, Berlin N, Moskowitz A, Donnino MW. Thiamine administration in septic shock: a post hoc analysis of two randomized trials. Crit Care. 2024 Feb 6;28(1):41. doi: 10.1186/s13054-024-04818-1.

    PMID: 38321529DERIVED

MeSH Terms

Conditions

Shock, SepticSepsis

Interventions

Thiamine

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Results Point of Contact

Title
Michael W Donnino
Organization
BIDMC
mdonnino@bidmc.harvard.edu
617-754-2295

Study Officials

  • Michael W Donnino, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Michael W. Donnino, MD

Study Record Dates

First Submitted

February 17, 2010

First Posted

February 18, 2010

Study Start

February 1, 2010

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

May 15, 2017

Results First Posted

May 15, 2017

Record last verified: 2017-04

Locations

US(1)