Vasopressin Hemodynamic Response as a Septic Shock Subphenotype Indicator

Status Not yet recruiting

Clinical Trial Summary

The goal of this observational study is to learn about blood pressure response to the vasopressor drug vasopressin in people with septic shock. The main questions it aims to answer are: - Are the levels of molecules showing communication between cells different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication? - Are measurements found on echocardiography (heart ultrasound) different between people whose blood pressure improves and people whose blood pressure does not improve when given a vasopressor medication? Participants will be asked to contribute one or two blood samples. Participants who are ordered the drug vasopressin will contribute two blood samples. Both samples will be about two tablespoons for a total of about four tablespoons. One sample will be drawn before starting vasopressin infusion and the second sample will be drawn between one and six hours after starting the vasopressor drug infusion. At the same time points, advanced echocardiography pictures will be taken. Participants who are not ordered the drug vasopressin and only ordered the drug norepinephrine will contribute only one sample. At the time the sample is collected, advanced echocardiography pictures will be taken. This research also involves analyzing data obtained during the participant's hospital stay.

Clinical Trial Description

Septic shock mortality remains high at 33% in North America; current clinical predictors of poor outcomes in septic shock are suboptimal. In addition to antibiotics and intravenous fluids, vasoactive agents are initiated to restore effective tissue perfusion. Norepinephrine (NE) is the recommended first-line vasopressor, but adjunctive arginine vasopressin is used in over one-third of patients to improve blood pressure or decrease NE dosage. However, less than half of vasopressin recipients have a clinically-apparent hemodynamic response (defined as a decrease in NE dosage at 6 hours after vasopressin initiation). Vasopressors, particularly norepinephrine, are known to be immune modulators. Further, each vasopressor has its own unique effect on a patient's hemodynamic profile as assessed by echocardiography. In the current study, the investigators seek to clarify the link between vasopressin, immune response, and hemodynamic profile. The central goal of this proposal is to identify "vasopressin response" as an easily-identifiable bedside indicator of a distinct septic shock subphenotype. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06426407
Study type	Observational
Source	The Cleveland Clinic
Contact	Seth Bauer, PharmD
Phone	2169522553
Email	bauers@ccf.org
Status	Not yet recruiting
Phase
Start date	June 2024
Completion date	January 2026

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03592693` - Vitamin C, Hydrocortisone and Thiamine for Septic Shock	Phase 2
Terminated	`NCT01639664` - COMPACT 2 - COMbining Plasma-filtration and Adsorption Clinical Trial 2	N/A
Withdrawn	`NCT01601938` - Selenium Replacement and Serum Selenium Level in Severe Sepsis and Septic Shock Patients	Phase 2
Recruiting	`NCT00335907` - Protocol-driven Hemodynamic Support for Patients With Septic Shock	N/A
Completed	`NCT00000574` - Ibuprofen in Sepsis Study	Phase 3
Recruiting	`NCT04910841` - Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine	N/A
Active, not recruiting	`NCT04079829` - Postoperative Respiratory Abnormalities
Recruiting	`NCT04569942` - Australasian Resuscitation In Sepsis Evaluation: FLUid or Vasopressors In Emergency Department Sepsis	Phase 3
Recruiting	`NCT04934943` - "Mini Fluid Challenge Assessment: a Comparison Among Three Hemodynamic Tools"
Completed	`NCT01310790` - Strategy of Early Improvement of Tissue Oxygenation Decrease the Mortality of Severe Sepsis and Septic Shock	Phase 4
Completed	`NCT00241228` - Haemofiltration Study : IVOIRE (hIgh VOlume in Intensive Care)	N/A
Completed	`NCT00046072` - A Safety and Efficacy Study of Intravenous E5564 in Patients With Severe Sepsis	Phase 2
Withdrawn	`NCT03122678` - Thiamine Supplementation in Patients With Septic Shock	Phase 1
Recruiting	`NCT06155812` - Multimodal Vasopressor Strategy in Septic Shock	Phase 2/Phase 3
Completed	`NCT04178148` - Personalized Dose Optimization of Amikacin Guided by Pharmacokinetic Modeling Software in Patients With Septic Shock	N/A
Completed	`NCT01453270` - Emergency Department Management of Sepsis Patients: A Goal-Oriented Non-Invasive Sepsis Trial	N/A
Completed	`NCT04576819` - Role and Mechanisms of Lipid and Lipoprotein Dysregulation in Sepsis
Active, not recruiting	`NCT04055909` - Efficacy, Safety and Tolerability of Nangibotide in Patients With Septic Shock	Phase 2
Suspended	`NCT03193164` - Neuromuscular Electrical Stimulation and Septic Shock	N/A
Completed	`NCT04647552` - Effects of Hydrocortison Treatment on Angiotensin II and Angiotensin II Receptors in Patients With Septic Shock