Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490731
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-20
Brief Title:
Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients
Sponsor:
New Valley University
Organization:
New Valley University
Study Overview
Official Title:
Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients With Intraabdominal Sepsis A Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Inflammatory response and hemodynamic response in patients with intraabdominal sepsis and Effects of Dexmedetomidine versus ketamine on it
Detailed Description:
Severe sepsis is a major healthcare problem with a reported incidence of 1-2 in all hospitalizations It is a major cause of death in intensive care units worldwide and is the second leading cause of death in noncoronary intensive care unit patients Mortality remains high at 30-50 despite a better understanding of sepsis pathophysiology and improved advanced care in the past decade It is defined as a life-threatening organ dysfunction with a Sequential Organ Failure Assessment SOFA score 2 and a mortality of over 10 in hospitals These patients suffer from circulatory disorders including decreased intravascular volume peripheral vasodilatation and myocardial dysfunction increased metabolism which may result in hypoxia due to the imbalance between systemic oxygen delivery and oxygen demand
The pathophysiology of septic shock is well known However septic shock therapy is still limited and the mortality of patients with septic shock remains high The innate immune system is the first line of defense mechanism against pathogens The activation of the immunocompetent cells including macrophages monocytes natural killer cells dendritic cells and endothelial cells mediate the innate immune response to respond to pathogens or their components Activated immune cells also secrete pro-inflammatory mediators such as cytokines interleukin IL-1 IL-6 IL-8 tumor necrosis factor-α TNF-α prostaglandins and histamine These mediators act on vascular endothelial cells and cause vasodilation increased vascular permeability and recruitment of neutrophils to the tissue
The coagulation cascade is activated locally by upregulating endothelial tissue factors and decreased thrombomodulin and its antithrombotic products
Ketamine is one of the most rational anaesthetic and sedative agents for patients with sepsis because of its ability to maintain hemodynamics Ketamine also suppresses pro-inflammatory cytokines apoptosis and increases intracellular calcium In the hyperinflammatory phase ketamine can also reduce anti-inflammatory cytokines such as IL-10 in the hypoinflammatory phase Ketamine was thought to reduce the risk of secondary infection in the hypoinflammatory phase However there has yet to be further research on this hypothesis Therefore ketamine is expected to be developed as a candidate for immunotherapy in sepsis
Dexmedetomidine alpha2 receptor agonist has anti-inflammatory and anti-bacterial effects which are superior to those of gamma-aminobutyric acid agonists such as benzodiazepines and propofol Furthermore it also reduces neuronal apoptosis high doses of central alpha-2-agonists like dexmedetomidine increase vasopressor responsiveness Moreover even in non-septic patients alpha-2-agonists are associated with lower vasopressor requirements increased arterial blood pressure and enhanced baroreceptor response
The pathophysiology of septic shock is well known However septic shock therapy is still limited and the mortality of patients with septic shock remains high The innate immune system is the first line of defense mechanism against pathogens The activation of the immunocompetent cells including macrophages monocytes natural killer cells dendritic cells and endothelial cells mediate the innate immune response to respond to pathogens or their components Activated immune cells also secrete pro-inflammatory mediators such as cytokines interleukin IL-1 IL-6 IL-8 tumor necrosis factor-α TNF-α prostaglandins and histamine These mediators act on vascular endothelial cells and cause vasodilation increased vascular permeability and recruitment of neutrophils to the tissue
The coagulation cascade is activated locally by upregulating endothelial tissue factors and decreased thrombomodulin and its antithrombotic products
Ketamine is one of the most rational anaesthetic and sedative agents for patients with sepsis because of its ability to maintain hemodynamics Ketamine also suppresses pro-inflammatory cytokines apoptosis and increases intracellular calcium In the hyperinflammatory phase ketamine can also reduce anti-inflammatory cytokines such as IL-10 in the hypoinflammatory phase Ketamine was thought to reduce the risk of secondary infection in the hypoinflammatory phase However there has yet to be further research on this hypothesis Therefore ketamine is expected to be developed as a candidate for immunotherapy in sepsis
Dexmedetomidine alpha2 receptor agonist has anti-inflammatory and anti-bacterial effects which are superior to those of gamma-aminobutyric acid agonists such as benzodiazepines and propofol Furthermore it also reduces neuronal apoptosis high doses of central alpha-2-agonists like dexmedetomidine increase vasopressor responsiveness Moreover even in non-septic patients alpha-2-agonists are associated with lower vasopressor requirements increased arterial blood pressure and enhanced baroreceptor response
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None