Septic Shock Clinical Trial
Official title:
Effect of Intravenous Hydrocortison on Post-ischemic Brachial Artery Dilation and on Thenar Oxygen Saturation in Adult Septic Shock. A Human Placebo-controlled Randomized Study.
The main objectives of the study are 1)to examine the immediate (2 hours) and delayed (8 hours) effects of intravenous hydrocortison on macro and microvascular post-ischemic vasoreactivity, in septic shock adult patients; 2) to examine possible correlations between post-ischemic flow-mediated dilation (FMD) of the brachial artery (assessed by ultrasound imaging) and post-ischemic recovery slope of the thenar oxygen saturation (StO2) (assessed by near-infrared spectroscopy).
Two primary end points, considered as reflecting vasoreactivity will be assessed :
1. Flow-mediated dilation (FMD) of the brachial artery, measured by ultrasound imaging,
expressed in mm or in percentage, will be calculated from artery diameters measured
before and after a vascular occlusion test (cuff around arm or forearm).
2. recovery slope of thenar oxygen saturation (StO2), assessed by near infrared
spectroscopy (NIRS), expressed in %/second, will be recorded after the vascular
occlusion test.
The two primary end points (FMD and recovery slope of StO2)will be assessed at the following
timepoints :
- baseline (before first injection of placebo or hydrocortison)
- 2 hours after first injection of placebo or hydrocortison
- 2 hours after second injection of placebo or hydrocortison (i.e. 8 hours after first
injection)
- 4 to 6 hours after third injection
- 4 to 6 hours after fourth injection (optional)
;
| 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 |
NCT02580240 -
Administration of Hydrocortisone for the Treatment of Septic Shock
|
N/A | |
| Recruiting |
NCT02565251 -
Volemic Resuscitation in Sepsis and Septic Shock
|
N/A | |
| Recruiting |
NCT02676427 -
Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
|
||
| Terminated |
NCT02335723 -
ASSET - a Double-Blind, Randomized Placebo-Controlled Clinical Investigation With Alteco® LPS Adsorber
|
N/A | |
| Not yet recruiting |
NCT02547467 -
TOADS Study: TO Assess Death From Septic Shock.
|
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 |
NCT02204852 -
Co-administration of Iloprost and Eptifibatide in Septic Shock Patients
|
Phase 2 |