Septic Shock Clinical Trial
Official title:
Hypertonic Saline and Terlipressin Linked To an Early Goal-Driven Protocol for Septic Shock or Sepsis-Associated Hypotension: A Pilot Trial (HYSATESS)
In hypotensive septic patients with controlled source, an hemodynamic management protocol
including hypertonic saline (HS)and terlipressin improves MOD (Multiple Organ Dysfunction)
Score by at least 3 points compared to the use of physiologic saline and norepinephrine.
The appropriate design for this trial would be factorial. For the time being, will consider
de intervention as a whole unit for this pilot study. In the future an appropriately sized
factorial multicentric study shall be necessary.
Other goals of the pilot study:
1. HS restores preload parameters adequately
2. HS associated with terlipressin normalizes blood pressure in septic shock
3. HS associated with terlipressin maintains plasma sodium levels 130-155mEq/L
4. There is an inverse relationship between plasma sodium and procalcitonin levels
5. HS increases plasma levels of vasopressin (AVP)
6. HS rises levels of cortisol but not of adrenocorticotropic hormone (ACTH)
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| 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 |
NCT02676427 -
Fluid Responsiveness in Septic Shock Evaluated by Caval Ultrasound Doppler Examination
|
||
| Recruiting |
NCT02580240 -
Administration of Hydrocortisone for the Treatment of Septic Shock
|
N/A | |
| Recruiting |
NCT02565251 -
Volemic Resuscitation in Sepsis and Septic Shock
|
N/A | |
| 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 |
NCT02204852 -
Co-administration of Iloprost and Eptifibatide in Septic Shock Patients
|
Phase 2 | |
| Completed |
NCT02079402 -
Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care
|
Phase 4 |