Haemodynamic ReboundPhase 1/2NCT06490731
Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients
A Phase 1/2 study testing Dexmedetomidine and Ketamine in people with Haemodynamic Rebound, run by New Valley University at 1 site in Egypt.
Trial summary
Inflammatory response and hemodynamic response in patients with intraabdominal sepsis and Effects of Dexmedetomidine versus ketamine on it . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Haemodynamic Rebound
- What is being tested?
- Dexmedetomidine and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Oct 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Adult patients admitted to ICU after ileus surgery (perforated viscus, infarcted bowel, strangulated hernia, anastomotic leakage, diverticulitis, and intestinal obstruction), and who will be expected to require postoperative sedation and ventilation.
- Abdominal sepsis was determined as organ dysfunction with a substantial change in overall SOFA score (2) ≥ 2 points because of intra-abdominal sepsis.
Who cannot join
- • Known allergy to ketamine, dexmedetomidine,
- Confirmed pregnancy,
- Heart failure (class 3 or 4 of the New York Heart Association),
- Renal failure (RIFLE classification),
- Liver failure (manifested by serum total protein concentration <3 g/dl and total bilirubin >5 mg/dl)
- Known or suspected brain death.
- Patients who receive neuromuscular blockers during the first 48 hours of ICU admission will also be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
asyut University
Asyut
Alaa attia, professur, 01099923117
About this study
Official title: Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients With Intraabdominal Sepsis: A Randomized Controlled Study
Inflammatory response and hemodynamic response in patients with intraabdominal sepsis and Effects of Dexmedetomidine versus ketamine on it .
Read the 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 .
- Conditions
- Haemodynamic Rebound
- Being tested
- Dexmedetomidine, Ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Patients will receive dexmedetomidine
KetamineDrug
patients Will receive ketamine
| Study group | Role | What they receive |
|---|---|---|
| Patients will receive dexmedetomidine | Active comparator | Patients will receive dexmedetomidine (Precedex®; 200 µg/2 ml; at one µg/kg loading dose over 10 minutes followed by a 0.5 µg/kg/hr. maintenance dose for 48 hours Dexmedetomidine will be diluted in normal saline at a 4 µg/ ml concentration Receives: Drug: Dexmedetomidine |
| Patients will receive ketamine | Active comparator | Patients will receive ketamine at one mg/kg IV loading dose over 10 minutes, then a continuous infusion starting at 300 µg /kg/hr over 48 hours Receives: Drug: Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Effect of the study drugs as sedative agents on blood pressure in mechanically ventilated septic patients after abdominal exploration for intestinal surgery.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Apr 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodynamic ReboundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ismail Abdelsabour, New Valley University
- Investigators
- Ahmed Ismail Abdel Sabour, MD, Principal investigator, NewValley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06490731
- Sponsor's protocol ID
- New valley anesthesia 4
- Status last verified
- May 2026
- First submitted
- 20 Jun 2024
- Last updated
- 7 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine Versus Ketamine on Inflammatory Response and Hemodynamic in Patients With Intraabdominal Sepsis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06490731
- Acronym / sponsor ID
- New valley anesthesia 4
- Conditions
- Haemodynamic Rebound
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients will receive dexmedetomidine | Active comparator | Drug: DexmedetomidinePatients will receive dexmedetomidine (Precedex®; 200 µg/2 ml; at one µg/kg loading dose over 10 minutes followed by a 0.5 µg/kg/hr. maintenance dose for 48 hours Dexmedetomidine will be diluted in normal saline at a 4 µg/ ml concentration |
| Patients will receive ketamine | Active comparator | Drug: KetaminePatients will receive ketamine at one mg/kg IV loading dose over 10 minutes, then a continuous infusion starting at 300 µg /kg/hr over 48 hours |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • Adult patients admitted to ICU after ileus surgery (perforated viscus, infarcted bowel, strangulated hernia, anastomotic leakage, diverticulitis, and intestinal obstruction), and who will be expected to require postoperative sedation and ventilation.
Key exclusion criteria (7 listed)
- • Known allergy to ketamine, dexmedetomidine,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidinePatients will receive dexmedetomidine | Drug | Patients will receive dexmedetomidine |
| Ketaminepatients Will receive ketamine | Drug | Patients will receive ketamine |
Primary outcome
blood pressure
Time frame: 48 hours
Effect of the study drugs as sedative agents on blood pressure in mechanically ventilated septic patients after abdominal exploration for intestinal surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ahmed Ismail Abdel Sabour, MD principal investigator
NewValley University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Dexmedetomidine and Ketamine in people with Haemodynamic Rebound, run by New Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Ismail ABDEL sabour, MD (01097845491 ext. 2, ahmed_ismail87@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood pressure (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.