Septic PeritonitisPhase 4NCT04718714
Effects of Dexmedetomidine vs Propofol in Patients With Intra-abdominal Sepsis
A Phase 4 study testing Midazolam, Propofol and Dexmedetomidine in people with Septic Peritonitis, run by Assiut University at 1 site in Egypt.
Trial summary
Sepsis is defined as systemic response to infection ,and it is a main problem in ICU and despite advance in supportive care, the mortality rate in patients with severe sepsis continues to exceed 30% [Bone RC 1993].The effects of bacterial invasion of body tissues result from combined actions of enzymes and toxins… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septic Peritonitis
- What is being tested?
- Midazolam, Propofol 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
- 23 Jan 2021to 10 Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients aged18 years old or more and had the criteria of intraabdominal sepsis as evident by quick sofa score of 2 or more and have done intraabdominal surgical procedures
Who cannot join
- children pregnant women Patients who receive neuromascular blockers during the first 48 hours of ICU admission known allergy or contraindication to propofol ,dexemedetomidine or midazolam known or suspected brain death
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dexmedetomidine vs Propofol on Inflammatory Response and Intra-abdominal Pressure in Patients With Intra-abdominal Sepsis; a Randomized Clinical Trial
Sepsis is defined as systemic response to infection ,and it is a main problem in ICU and despite advance in supportive care, the mortality rate in patients with severe sepsis continues to exceed 30% [Bone RC 1993].The effects of bacterial invasion of body tissues result from combined actions of enzymes and toxins produced by micro-organisms themselves and by a network of proinflammatory mediators and cytokines as tumour necrosis factor α and interleukin 6 which are overexpressed after various noxious insults[P.Delong et al. 2006],[ Yealy et al. 2014].
the patients who are subjected to abdominal surgery in order to treat the cause surgically,and many of these surgical procedures are lengthy and are at risk for either pre-operatively or post-operatively with steady increase in intra-abdominal pressure(IAP) [Malbrain ML et al. 2007] Intra-abdominal hypertension (IAH) is defined as IAP equal to or greater than 12 mmHg whereas abdominal compartment syndrome (ACS) is defined as IAP greater than 20 mmHg, abdominal perfusing pressure (APP) is used to predict prognosis of both IAH and ACS [Malbrain ML et al. 2006].
Read more
The choice for using a sedative agent in ICU for mechanically ventilated patients post-operatively is therefore a crucial one as these patients are under hyperstress state and often require drugs for sedation and analgesia[ Chanques G et al. 2006].
Analgesics and sedation agents have clearly been shown to alter cellular function and other mediators of immune system with wide range of immune modulation ,ranging from immunosuppressive effects to significant anti-inflammatory effects during endotoxaemia[ Taniguchi et al. 2004] Also sedation and /or analgesia have the potential to reduce IAP through improvement of abdominal wall compliance.
Although propofol and dexmedetomidine are used for sedation in ICU there are limited data on their effects on inflammatory responses and IAP in septic patients.
In clinical practice, septic patients treated with dexmedetomidine have shorter time on the ventilator as compared with those treated with lorazepam, a benzodiazepine and this beneficial effect of dexmedetomidine is more pronounced in septic patients than in nonseptic patients. This outcome may be partly the result of dexmedetomidine induced reduction in pulmonary inflammatory mediators and lung tissue damage.[ M. Ueki et al. 2014] Midazolam is known to inhibit certain aspects of the immune function. It was suggested that benzodiazepines bind to specific receptors on macrophages and inhibit their capacity to produce IL-1, IL-6, and TNFα.
Propofol, nowadays, has become a preferred sedative in ICU because it offers advantages over benzodiazepines in terms of lack of accumulation, quick onset, easy adjustment, and fast recovery after discontinuation. [ Jacobi J et al. 2002]
Read the detailed description
After surgery patients will be transferred to the ICU and will be randomly allocated by use of sealed envelopes ;into one of three groups 20 patients each.
All ICU measurements will be recorded by an observer
The following data will be collected:
- Patients' demographic and clinical data including age, sex, weight ,operative procedure time and type and patient's SOFA score.
- Mean arterial pressure, heart rate (HR), central venous pressure (CVP), and temperature will be continuously monitored . Urine output will be measured hourly and fluid balance will be calculated every 12 hours. All measurements will be obtained at the start of the study (baseline), then at the 24th and 48th hours.
- Lactate, platelets, leukocytes, bilirubin, alanine aminotransferase, and creatinine will be determined at the same times TNF-α, IL-1β, and IL-6 levels will be obtained at baseline, and at the 24th and 48 th hours.
- Intraabdominal pressure and abdominal perfusion pressure will be measured at baseline (15 min before start of the study) and at the 24th and 48th hours per the study protocol.
- Behavioral pain scale, ramsay sedation score and post operative analgesics requirements as a rescue analgesia.
- Duration of mechanical ventilation and length of ICU stay.
- Conditions
- Septic Peritonitis
- Being tested
- Midazolam, Propofol, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
loading dose intravenous infusion of 0.2 mg/kg over 10 minutes followed by a maintenance dose of 0.02 -0.2 mg /kg/hr. over 24 hours.
PropofolDrug
loading dose intravenous infusion of one mg/kg over 15 minutes followed by a maintenance dose of 20-80 microgram/kg/min. over 24 hours.
DexmedetomidineDrug
loading dose of dexmedetomidine of one µg/kg over 10 minutes followed by maintenance dose of 0.2 -1.5 µg/kg/hr. over 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| midazolam | Active comparator | postoperative ventilation and sedation with continuous intravenous infusion of midazolam only for 24 hours Receives: Drug: Midazolam |
| propofol | Active comparator | postoperative ventilation and sedation with continuous intravenous infusion of propofol only for 24 hours Receives: Drug: Propofol |
| dexmedetomidine | Experimental | postoperative ventilation and sedation with continuous intravenous infusion of dexmedetomidine only for 24 hours Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
interleukin 1 plasma concentration
interleukin 1 plasma concentration will be measured three times, at admission ,24 hours after admission and 48 hours after admission
Measured: 48 hours
interleukin 6 plasma concentration
interleukin 6 plasma concentration will be measured three times ,at admission ,24 hours after admission and 48 hours after admission
Measured: 48 hours
intraabdominal pressure per mmHg
intraabdominal pressure will be measured three times ,at admission ,24 hours after admission and 48 hours after admission
Measured: 48 hours
Secondary outcomes (1)
difference of mean time of ventilator free days
difference of mean time of ventilator free days between the three arms
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start23 Jan 2021
- Primary completion10 Apr 2021
- Study completion10 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic PeritonitisStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibraheem Abdelmageed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718714
- Sponsor's protocol ID
- 00008718
- Status last verified
- Apr 2021
- First submitted
- 15 Jan 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine vs Propofol on Inflammatory Response and Intra-abdominal Pressure in Patients With Intra-abdominal Sepsis; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04718714
- Acronym / sponsor ID
- 00008718
- Conditions
- Septic Peritonitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 10 Apr 2021 (actual)
- Study completion
- 10 Apr 2021 (actual)
- First posted
- 22 Jan 2021 (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.
Sepsis is defined as systemic response to infection ,and it is a main problem in ICU and despite advance in supportive care, the mortality rate in patients with severe sepsis continues to exceed 30% [Bone RC 1993].The effects of bacterial invasion of body tissues result from combined actions of enzymes and toxins produced by micro-organisms themselves and by a network of proinflammatory mediators and cytokines as tumour necrosis factor α and interleukin 6 which are overexpressed after various noxious insults[P.Delong et al. 2006],[ Yealy et al. 2014].
the patients who are subjected to abdominal surgery in order to treat the cause surgically,and many of these surgical procedures are lengthy and are at risk for either pre-operatively or post-operatively with steady increase in intra-abdominal pressure(IAP) [Malbrain ML et al. 2007] Intra-abdominal hypertension (IAH) is defined as IAP equal to or greater than 12 mmHg whereas abdominal compartment syndrome (ACS) is defined as IAP greater than 20 mmHg, abdominal perfusing pressure (APP) is used to predict prognosis of both IAH and ACS [Malbrain ML et al. 2006].
The choice for using a sedative agent in ICU for mechanically ventilated patients post-operatively is therefore a crucial one as these patients are under hyperstress state and often require drugs for sedation and analgesia[ Chanques G et al. 2006].
Analgesics and sedation agents have clearly been shown to alter cellular function and other mediators of immune system with wide range of immune modulation ,ranging from immunosuppressive effects to significant anti-inflammatory effects during endotoxaemia[ Taniguchi et al. 2004] Also sedation and /or analgesia have the potential to reduce IAP through improvement of abdominal wall compliance.
Although propofol and dexmedetomidine are used for sedation in ICU there are limited data on their effects on inflammatory responses and IAP in septic patients.
In clinical practice, septic patients treated with dexmedetomidine have shorter time on the ventilator as compared with those treated with lorazepam, a benzodiazepine and this beneficial effect of dexmedetomidine is more pronounced in septic patients than in nonseptic patients. This outcome may be partly the result of dexmedetomidine induced reduction in pulmonary inflammatory mediators and lung tissue damage.[ M. Ueki et al. 2014] Midazolam is known to inhibit certain aspects of the immune function. It was suggested that benzodiazepines bind to specific receptors on macrophages and inhibit their capacity to produce IL-1, IL-6, and TNFα.
Propofol, nowadays, has become a preferred sedative in ICU because it offers advantages over benzodiazepines in terms of lack of accumulation, quick onset, easy adjustment, and fast recovery after discontinuation. [ Jacobi J et al. 2002]
Detailed description
After surgery patients will be transferred to the ICU and will be randomly allocated by use of sealed envelopes ;into one of three groups 20 patients each.
All ICU measurements will be recorded by an observer
The following data will be collected:
- Patients' demographic and clinical data including age, sex, weight ,operative procedure time and type and patient's SOFA score.
- Mean arterial pressure, heart rate (HR), central venous pressure (CVP), and temperature will be continuously monitored . Urine output will be measured hourly and fluid balance will be calculated every 12 hours. All measurements will be obtained at the start of the study (baseline), then at the 24th and 48th hours.
- Lactate, platelets, leukocytes, bilirubin, alanine aminotransferase, and creatinine will be determined at the same times TNF-α, IL-1β, and IL-6 levels will be obtained at baseline, and at the 24th and 48 th hours.
- Intraabdominal pressure and abdominal perfusion pressure will be measured at baseline (15 min before start of the study) and at the 24th and 48th hours per the study protocol.
- Behavioral pain scale, ramsay sedation score and post operative analgesics requirements as a rescue analgesia.
- Duration of mechanical ventilation and length of ICU stay.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| midazolam | Active comparator | Drug: Midazolampostoperative ventilation and sedation with continuous intravenous infusion of midazolam only for 24 hours |
| propofol | Active comparator | Drug: Propofolpostoperative ventilation and sedation with continuous intravenous infusion of propofol only for 24 hours |
| dexmedetomidine | Experimental | Drug: Dexmedetomidinepostoperative ventilation and sedation with continuous intravenous infusion of dexmedetomidine only for 24 hours |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients aged18 years old or more and had the criteria of intraabdominal sepsis as evident by quick sofa score of 2 or more and have done intraabdominal surgical procedures
Key exclusion criteria (1 listed)
- children pregnant women Patients who receive neuromascular blockers during the first 48 hours of ICU admission known allergy or contraindication to propofol ,dexemedetomidine or midazolam known or suspected brain death
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 |
|---|---|---|
| Midazolamloading dose intravenous infusion of 0.2 mg/kg over 10 minutes followed by a maintenance dose of 0.02 -0.2 mg /kg/hr. over 24 hours. | Drug | midazolam |
| Propofolloading dose intravenous infusion of one mg/kg over 15 minutes followed by a maintenance dose of 20-80 microgram/kg/min. over 24 hours. | Drug | propofol |
| Dexmedetomidineloading dose of dexmedetomidine of one µg/kg over 10 minutes followed by maintenance dose of 0.2 -1.5 µg/kg/hr. over 24 hours. | Drug | dexmedetomidine |
Primary outcome
interleukin 1 plasma concentration
Time frame: 48 hours
interleukin 1 plasma concentration will be measured three times, at admission ,24 hours after admission and 48 hours after admission
interleukin 6 plasma concentration
Time frame: 48 hours
interleukin 6 plasma concentration will be measured three times ,at admission ,24 hours after admission and 48 hours after admission
intraabdominal pressure per mmHg
Time frame: 48 hours
intraabdominal pressure will be measured three times ,at admission ,24 hours after admission and 48 hours after admission
1 secondary outcome
difference of mean time of ventilator free days
Time frame: 28 days
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 27 Apr 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Midazolam, Propofol and Dexmedetomidine in people with Septic Peritonitis, run by Assiut 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 1 inclusion and 1 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 27 Apr 2021. 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?
interleukin 1 plasma concentration (time frame: 48 hours). The study lists 3 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 27 Apr 2021.