NCT03700346

Brief Summary

We conducted this study aiming to assess the performance of muscle Lactate and lactate to pyruvate (L/P) ratio clearance in predicting mortality in septic shock patients by using microdialysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

September 30, 2018

Last Update Submit

April 18, 2021

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • Clearances of muscle lactate, and L/P ratio

    Clearances of muscle lactate, and L/P ratio were defined as the percentage change in muscle lactate level or L/P ratio compared to baseline (H0) values.

    3 days

Secondary Outcomes (4)

  • muscle lactate

    3 days

  • muscle pyruvate

    3 days

  • muscle glucose

    3 days

  • muscle glycerol

    3 days

Study Arms (2)

survivors

OTHER

survivor at ICU discharge muscle microdialysis

Device: microdialysis

Non survivors

OTHER

death before ICU discharge muscle microdialysis

Device: microdialysis

Interventions

microdialysisDEVICE

Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis

Non survivorssurvivors

Eligibility Criteria

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

You may qualify if:

  • patients fulfilled the criteria of septic shock

You may not qualify if:

  • pregnancy, uncontrolled hemorrhage, terminal heart failure, significant valvular heart disease, documented or suspected acute coronary syndrome, and limitations on the use of inotropes: left ventricle outflow obstruction, systolic anterior motion of the mitral valve.
  • incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Military hospital of tunis

Tunis, Mont Fleury, 1008, Tunisia

Location

Military Hopital of Tunis

Tunis, 1008, Tunisia

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Microdialysis

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

DialysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • zied Hajjej, dr

    Military hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2018

First Posted

October 9, 2018

Study Start

January 1, 2018

Primary Completion

October 30, 2018

Study Completion

December 31, 2018

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)