Haemodynamic InstabilityPhase 4ARDSNCT05951387
Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients
A Phase 4 study testing dexmedetomidine plus ketamine and Dexmedetomidine in people with Haemodynamic Instability, run by Benha University at 1 site in Egypt.
Trial summary
The goal of this clinical trial study is to compare dexmedetomidine versus the combination of dexmedetomidine with ketamine in hemodynamic changes and sedative effects in ARDS patients who are in need of mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haemodynamic Instability
- What is being tested?
- dexmedetomidine plus ketamine and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 5 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with ARDS with the following:
- Those whose duration of endotracheal intubation was > 120 h
- those whose ages were 18- 70 years old
- those with acute physiology and chronic health evaluation (APACHE) II scores > 12 points.
Who cannot join
- patients with a history of allergy to ketamine or dexmedetomidine
- Pregnant women,
- patients in the early stage of recovery,
- patients with unstable hemodynamics, bradycardia, sinus arrest, or other cardiac arrhythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Hemodynamic Changes and Sedation Effect of Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients, Randomized Clinical Trial
The goal of this clinical trial study is to compare dexmedetomidine versus the combination of dexmedetomidine with ketamine in hemodynamic changes and sedative effects in ARDS patients who are in need of mechanical ventilation. The main question[s] it aims to answer are:
- [question 1]: Which dose that get the target in sedation, single and combined drugs?
- [question 2]: In which drug group that hemodynamic did not affect Participants will be patients with ARDS that will be divided into two group the first ont will receive dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and the second one will receive dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.
Read the detailed description
This study will include 60 patients with ARDS who will be admitted to the intensive care unit (ICU) and chest ICU of Banha university hospitals during the period between June 2023 and June 2024.
ARDS will be diagnosed based on the presence of new or worsening symptoms within one week of a known clinical insult; bilateral opacities on anteroposterior chest X-ray that are not due to effusions, nodules or lobar or lung collapse; and hypoxemia, defined as arterial oxygen tension/fraction of inspired oxygen (Pao2/FiO2) < 300 mm Hg and a minimum positive end-expiratory pressure ≥ 5 cm H2O, that is not explained by heart failure or fluid overload.
Patients were divided randomly into two groups. Group A (n = 30); received with starting dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and Group B (n = 30); received dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.
All patients will be subjected to the following:
- Thorough history taking and clinical examination
- Calculation of acute physiology and chronic health evaluation (APACHE) score at time of ICU admission
- Sedation score calculation using the Richmond Agitation-Sedation Scale (RASS)
- ECG, blood pressure monitoring
- Measurement of plasma C-reactive protein (CRP) level before and after initiation of sedation.
- Measurement of oxygenation status (Pao2/Fio2) before and at 24, 48, 72, and 120 h after the administration of the sedatives
- Any adverse effects related to sedation or intubation will be recoded
All data will be tabulated and statistically analyzed
- Conditions
- Haemodynamic Instability
- Being tested
- dexmedetomidine plus ketamine, Dexmedetomidine
- Keywords
- ARDS, Dexmedetomidine, ketamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexmedetomidine plus ketamineDrug
Also called Group A
titrating the dose of dexmedetomidine mixed with ketamine (staring dose 0.5ug/kg/hr, 0.5mg/kg/hr respectively)to achieve full sedation
DexmedetomidineDrug
Also called Group B
starting intravenous infusion with dexmedetomidine starting at dose 0.5ug/kg//hr and titrate the dose to achieve full sedation
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine plus ketamine | Active comparator | starting intravenous infusion dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h to 30 mechanically ventilated ARDS patient Receives: Drug: dexmedetomidine plus ketamine |
| high dose dexmedetomidine | Active comparator | dexmedetomidine at 0.5 µg/kg/h intravenous infusion only to be titrated to achieve full sedation to 30 mechanically ventilated ARDS patient Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygenation parameter
change of PaO2/FiO2
Measured: 24-27 hours
positive end expiratory pressure (PEEP)
change of PEEP parameter that need to maintain oxygen saturation above 88%
Measured: 24-27 hours
Secondary outcomes (1)
serum level of C-reactive protein (CRP)
change of serum level of CRP (mg/dl)
Measured: 24-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsayed Elnaggar, Benha University
- Investigators
- Marwa Elnaggar, MD, Study director, Benha University, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05951387
- Sponsor's protocol ID
- RC 37-5-2023
- Acronym
- ARDS
- Status last verified
- Jul 2023
- First submitted
- 14 Jun 2023
- Last updated
- 11 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Hemodynamic Changes and Sedation Effect of Dexmedetomidine Versus Dexmedetomidine with Ketamine in Mechanically Ventilated ARDS Patients, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05951387
- Acronym / sponsor ID
- ARDS / RC 37-5-2023
- Conditions
- Haemodynamic Instability
- Keywords
- ARDS, Dexmedetomidine, ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 19 Jul 2023 (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.
The goal of this clinical trial study is to compare dexmedetomidine versus the combination of dexmedetomidine with ketamine in hemodynamic changes and sedative effects in ARDS patients who are in need of mechanical ventilation. The main question[s] it aims to answer are:
- [question 1]: Which dose that get the target in sedation, single and combined drugs?
- [question 2]: In which drug group that hemodynamic did not affect Participants will be patients with ARDS that will be divided into two group the first ont will receive dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and the second one will receive dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.
Detailed description
This study will include 60 patients with ARDS who will be admitted to the intensive care unit (ICU) and chest ICU of Banha university hospitals during the period between June 2023 and June 2024.
ARDS will be diagnosed based on the presence of new or worsening symptoms within one week of a known clinical insult; bilateral opacities on anteroposterior chest X-ray that are not due to effusions, nodules or lobar or lung collapse; and hypoxemia, defined as arterial oxygen tension/fraction of inspired oxygen (Pao2/FiO2) < 300 mm Hg and a minimum positive end-expiratory pressure ≥ 5 cm H2O, that is not explained by heart failure or fluid overload.
Patients were divided randomly into two groups. Group A (n = 30); received with starting dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h and Group B (n = 30); received dexmedetomidine at 0.5 µg/kg/h infusion only. In both the groups, studied drugs will be titrated to achieve target sedation.
All patients will be subjected to the following:
- Thorough history taking and clinical examination
- Calculation of acute physiology and chronic health evaluation (APACHE) score at time of ICU admission
- Sedation score calculation using the Richmond Agitation-Sedation Scale (RASS)
- ECG, blood pressure monitoring
- Measurement of plasma C-reactive protein (CRP) level before and after initiation of sedation.
- Measurement of oxygenation status (Pao2/Fio2) before and at 24, 48, 72, and 120 h after the administration of the sedatives
- Any adverse effects related to sedation or intubation will be recoded
All data will be tabulated and statistically analyzed
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine plus ketamine | Active comparator | Drug: dexmedetomidine plus ketaminestarting intravenous infusion dose of dexmedetomidine 0.5 µg/kg/h mixed with ketamine 0.5 mg/kg/h to 30 mechanically ventilated ARDS patient |
| high dose dexmedetomidine | Active comparator | Drug: Dexmedetomidinedexmedetomidine at 0.5 µg/kg/h intravenous infusion only to be titrated to achieve full sedation to 30 mechanically ventilated ARDS patient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with ARDS with the following:
Key exclusion criteria (4 listed)
- patients with a history of allergy to ketamine or dexmedetomidine
- Pregnant women,
- patients in the early stage of recovery,
- patients with unstable hemodynamics, bradycardia, sinus arrest, or other cardiac arrhythmias
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 |
|---|---|---|
| dexmedetomidine plus ketamineAlso: Group Atitrating the dose of dexmedetomidine mixed with ketamine (staring dose 0.5ug/kg/hr, 0.5mg/kg/hr respectively)to achieve full sedation | Drug | dexmedetomidine plus ketamine |
| DexmedetomidineAlso: Group Bstarting intravenous infusion with dexmedetomidine starting at dose 0.5ug/kg//hr and titrate the dose to achieve full sedation | Drug | high dose dexmedetomidine |
Primary outcome
oxygenation parameter
Time frame: 24-27 hours
change of PaO2/FiO2
positive end expiratory pressure (PEEP)
Time frame: 24-27 hours
change of PEEP parameter that need to maintain oxygen saturation above 88%
1 secondary outcome
serum level of C-reactive protein (CRP)
Time frame: 24-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Marwa Elnaggar, MD study director
Benha University, Faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing dexmedetomidine plus ketamine and Dexmedetomidine in people with Haemodynamic Instability, run by Benha 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 11 Feb 2025. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygenation parameter (time frame: 24-27 hours). The study lists 2 primary outcomes in all. 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 11 Feb 2025.