NCT02883803

Brief Summary

The main purpose at the early phase of septic shock on the evolution of organ failure judged by the SOFA (Sepsis Organ Failure Assessment score) score on Day 7 (or the day of death or the day of discharge from the intensive care unit if before Day 7) compared to SOFA score observed in patients in the control group. The secondary purpose is to assess the role of heterologous mesenchymal stem cells on the occurrence and duration of failure of each organ and on the mortality at day 28 and day 90. The safety of administration will be also assessed.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

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

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
3.3 years until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

October 25, 2019

Status Verified

July 1, 2019

Enrollment Period

1.9 years

First QC Date

August 25, 2016

Last Update Submit

October 24, 2019

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

  • SOFA score

    To assess the efficacy of a recovery treatment

    Day 7 (or death day or day of recovery unit exit if before day 7)

Secondary Outcomes (7)

  • Number of living days without catecholamines

    Day 28

  • Number of living days without mechanical ventilation

    Day 28

  • Number of living days without dialysis

    Day 28

  • Duration of residence time in recovery unit

    Day of exit from recovery unit, up to 90 days

  • Mortality, across all causes

    Day 28

  • +2 more secondary outcomes

Study Arms (2)

MSC

EXPERIMENTAL

Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 10\^6/kg heterologous mesenchymal stem cells in 250 ml albumin 4%, infused for 30 minutes in central venous line.

Biological: Injection of mesenchymal stem cells

Placebo

SHAM COMPARATOR

Patients hospitalized in recovery unit and having a very severe septic shock with community origin (≥ 2 organ failures other than hemodynamic) since less than 12 hours, will receive 250 ml albumin 4%, infused for 30 minutes in central venous line.

Biological: Injection of albumin alone

Interventions

Injection of mesenchymal stem cellsBIOLOGICAL

Injection of mesenchymal stem cells

MSC
Injection of albumin aloneBIOLOGICAL

Injection of albumin alone

Placebo

Eligibility Criteria

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

You may qualify if:

  • Septic shock of community origin since less than 12 hours. The onset time of septic shock is the time of catecholamine introduction( adrenaline, noradrenaline, or dopamine \> 8μg/kg/min)
  • At least 2 organ failure other than hemodynamic
  • Occurrence between Monday 8am and Friday 8am (for availability reasons of staff)
  • Signature of informed consent (patient/close relative or reliable person)
  • Affiliation to social security plan

You may not qualify if:

  • Non-septic shock
  • Nosocomial septic shock
  • PaO2/FiO2 \<100
  • Pregnant or breast-feeding woman
  • Brain death
  • Dying person
  • Therapeutic limitations
  • Participation to another current interventional clinical trial or since less than 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Service de Réanimation Médicale, Hôpital Bocage

Dijon, France

Location

Service de Réanimation Médicale, Hôpital Central

Nancy, France

Location

Hôpital Hautepierre, Service de réanimation médicale

Strasbourg, France

Location

UTCT, Hôpital Brabois

Vandœuvre-lès-Nancy, France

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

SepsisInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Sébastien GIBOT

    Service de Réanimation Médicale, Hôpital Central, 54035, Nancy Cedex

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sébastien GIBOT

CONTACT

+33383852970s.gibot@chu-nancy.fr

Daniele BENSOUSSAN

CONTACT

+33383153779d.bensoussan@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

December 1, 2019

Primary Completion

November 1, 2021

Study Completion

November 1, 2022

Last Updated

October 25, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)