Clinical Trials Logo
  1. Home
  2. Severe Sepsis
  3. NCT02361528

GM-CSF to Decrease ICU Acquired Infections — GRID  

Septic Shock Clinical Trial

Official title:
A Double-Blind, Randomized, Placebo-controlled Multicenter Trial of GRanulocyte-Macrophage Colony-stimulating Factor Administration to Decrease ICU Acquired Infections in Sepsis-induced ImmunoDepression

Clinical Trial Summary

The concept of acquired immunodeficiency after a first severe infection in the ICU is widely described in the literature. There is a dual risk: increased mortality and increased secondary infections. Several approaches of immunostimulatory treatments have been proposed in the literature. The treatment proposed by this study consists of the administration of Granulocyte-macrophage colony-stimulating factor (GM-CSF), colony stimulating factor widely used particularly in the USA where it is marketed. A phase 2 clinical trial was conducted in Germany in 2009.

The main objective is to measure the incidence of ICU-acquired infections in 2 groups of patients treated by GM-CSF or placebo. ICU patients at risk are defined as surviving at D3 from a severe sepsis or septic shock and presenting a sepsis associated immunodepression. The detection of immunosuppressed patients will be achieved by measuring the HLA-DR (Human Leucocyte Antigen DR)with a threshold of less to 8000 sites.

Our hypothesis is that the number of secondary infections (primary endpoint) will be significantly reduced in the treated group.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02361528
Study type Interventional
Source Hospices Civils de Lyon
Contact
Status Completed
Phase Phase 3
Start date September 14, 2015
Completion date June 1, 2018
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03649633 - Vitamin C, Steroids, and Thiamine, and Cerebral Autoregulation and Functional Outcome in Septic Shock Phase 1/Phase 2
Terminated NCT04117568 - The Role of Emergency Neutrophils and Glycans in Postoperative and Septic Patients
Completed NCT04227652 - Control of Fever in Septic Patients N/A
Completed NCT05629780 - Temporal Changes of Lactate in CLASSIC Patients N/A
Recruiting NCT04796636 - High-dose Intravenous Vitamin C in Patients With Septic Shock Phase 1
Terminated NCT03335124 - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock Phase 4
Recruiting NCT04005001 - Machine Learning Sepsis Alert Notification Using Clinical Data Phase 2
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Recruiting NCT05066256 - LV Diastolic Function vs IVC Diameter Variation as Predictor of Fluid Responsiveness in Shock N/A
Not yet recruiting NCT05443854 - Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01) Phase 3
Not yet recruiting NCT04516395 - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae N/A
Recruiting NCT02899143 - Short-course Antimicrobial Therapy in Sepsis Phase 2
Recruiting NCT02565251 - Volemic Resuscitation in Sepsis and Septic Shock N/A
Recruiting NCT02580240 - Administration of Hydrocortisone for the Treatment of Septic Shock N/A
Recruiting NCT02676427 - Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
Not yet recruiting NCT02547467 - TOADS Study: TO Assess Death From Septic Shock. N/A
Terminated NCT02335723 - ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber N/A
Completed NCT02638545 - Hemodynamic Effects of Dexmedetomidine in Septic Shock Phase 3
Completed NCT02306928 - PK Analysis of Piperacillin in Septic Shock Patients N/A
Completed NCT02079402 - Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Phase 4