Intracranial Pressure ChangesNCT05149586
Impact of Low Dose Ketamine Infusion in Septic Patient on Non-invasive Estimators of ICP
An observational study of Intracranial Pressure Changes, run by Zagazig University at 1 site in Egypt.
Trial summary
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 the intensive care units worldwide and is the second leading cause of death in noncoronary intensive care unit patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure Changes
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Dec 2021to 20 Mar 2023
- Phase
- Observational
- 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
Study population: septic patient admitted to intensive care units at zagazig university hospitals
Who may be able to join
- Patient acceptance (if conscious)
- Age >18years.
- Sex: both.
- septic patient.
Who cannot join
- Patient refusal
- Inflammatory lesions of the optic nerve itself (optic neuritis)
- Trauma to eye like rupture globe
- Glaucoma and optic atrophy
- History of previous intracranial surgery or spinal cord disease.
- Pregnant patients
- known allergy to ketamine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Principle Investigator
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 the 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 .
Sedation and analgesia in the intensive care unit (ICU) for patients with sepsis and tenuous hemodynamics can be challenging. Opioids and benzodiazepines can contribute to the pathophysiology of shock by exacerbating poor tissue perfusion through reduced cardiac contractility, and increased vasodilation as well as reducing the respiratory drive .
Read more
Sedation and analgesia management are both integral components of care in the intensive care unit (ICU). Although benzodiazepines have been the mainstay therapy for sedation in critically ill patients, their use has declined in recent years, with favoring of nonbenzodiazepines,such as propofol and dexmedetomidine .
A noticeable interest in ketamine infusion for sedation management in critically ill patients has developed among critical care physicians . The 2018 Pain, Agitation/ sedation, Delirium, Immobility, and Sleep disruption (PADIS) guideline suggested low-dose ketamine as an adjunct to opioid therapy for reducing opioid consumption in post-surgical adults admitted to the ICU .
Ketamine affects many pathways leading to inflammation cascade during sepsis. First, ketamine has an immunosuppressive effect on immune cells such as NK cell cytotoxic activity, neutrophil adhesion to endothelium, and chemotactic activity of neutrophils. Second, ketamine decreases Toll-like receptor expression, nuclear factorkB activity, and Raf/Raf cascade. Third, ketamine suppresses cytokines, superoxide, and nitric oxide productions, and reduces the mitochondrial membrane potential in macrophages. Finally, ketamine prevents the alteration of immune function in patients early after a major surgery, and increases survival in rats with sepsis .
Cerebral perfusion pressure (CPP) was compromised only in the patients with pre-existing intracranial hypertension and obstruction to the flow of cerebral spinal fluid. This has, however, led to the persistent belief that ketamine is contraindicated in patients with traumatic head injuries. Studies done subsequently have shown, however, that the effects of ketamine on cerebral haemodynamics and ICP are in fact variable and depend on both the presence of additional anaesthetic agents and PaCO2 values . Meta-analysis also suggests that Ketamine does not increase ICP and provides favorable hemodynamics . Meta analysis has shown that when ketamine is used in the presence of controlled ventilation, in conjunction with anaesthetics which reduce cerebral metabolism such as GABA receptor agonists, ICP is not increased.
The gold standard technique for ICP measurement is an intraventricular catheter[10]; however, this method is invasive and can have complications . Non-invasive ICP (nICP) measurement is a promising technique, still under development in adult and pediatric population .Optic nerve sheath diameter (ONSD) measurement using ocular ultrasonography is a safe, quick, reliable and reproducible technique for the assessment of ICP . Transcranial Doppler Ultrasonography (TCD) can also non-invasively assess ICP and CPP. Increased ICP produces characteristic changes in cerebral blood flow velocity (FV) waveform that can be assessed by decreases in the diastolic FV and increases in the pulsatility index (PI=systolic FV - diastolic FV) / mean FV) and several methods TCD derived have been proposed to assess non invasively ICP, showing good performance .
Sepsis-associated encephalopathy (SAE) usually manifests as sleep awakening cycle disturbance, cognitive impairment, delirium, and coma . Considering that brain edema secondary to SAE is one of the complications and causes of death in patients with sepsis, early detection of intracranial hypertension (ICH) is of great significance for timely intervention and improved prognosis. However, most patients with sepsis without intracranial infection have no indications for invasive intracranial pressure (ICP) monitoring; thus, non-invasive ICP monitoring was selected .
Therefore, in patients without invasive ICP monitoring, nICP methods may be useful for determining if ketamine infusion in septic patient will cause a pathological increase in ICP.
- Conditions
- Intracranial Pressure Changes
What is being measured
The primary outcome is the main question the study is designed to answer.
1- To compare the ICP monitoring after ketamine infusion in septic patient
To evaluate ICP monitoring parameters before and after ketamine infusion in septic patient (changes in ICP parameters)
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start10 Dec 2021
- Primary completion10 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial Pressure ChangesStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Essamedin Mamdouh Negm, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149586
- Sponsor's protocol ID
- 6928-6-9-2021
- Status last verified
- Apr 2023
- First submitted
- 24 Nov 2021
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Negm EM, Ali HT, Nofal HA, Mosallem A, Ahmed AE, Morsy AA, Elserafy TS, Elgohary M, Altaher KM, Sharaf El Deen S, Albialy HA, Gouda AM, Beniamen A. Impact of Low-Dose Ketamine Infusion on Intracranial Pressure and Hemodynamics in Septic Shock Patients. Neurocrit Care. 2026 Feb;44(1):136-145. doi: 10.1007/s12028-025-02302-4. Epub 2025 Jun 18.
PubMed 40533623
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principle Investigator
- ClinicalTrials.gov ID
- NCT05149586
- Acronym / sponsor ID
- 6928-6-9-2021
- Conditions
- Intracranial Pressure Changes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 8 Dec 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.
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 the 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 .
Sedation and analgesia in the intensive care unit (ICU) for patients with sepsis and tenuous hemodynamics can be challenging. Opioids and benzodiazepines can contribute to the pathophysiology of shock by exacerbating poor tissue perfusion through reduced cardiac contractility, and increased vasodilation as well as reducing the respiratory drive .
Sedation and analgesia management are both integral components of care in the intensive care unit (ICU). Although benzodiazepines have been the mainstay therapy for sedation in critically ill patients, their use has declined in recent years, with favoring of nonbenzodiazepines,such as propofol and dexmedetomidine .
A noticeable interest in ketamine infusion for sedation management in critically ill patients has developed among critical care physicians . The 2018 Pain, Agitation/ sedation, Delirium, Immobility, and Sleep disruption (PADIS) guideline suggested low-dose ketamine as an adjunct to opioid therapy for reducing opioid consumption in post-surgical adults admitted to the ICU .
Ketamine affects many pathways leading to inflammation cascade during sepsis. First, ketamine has an immunosuppressive effect on immune cells such as NK cell cytotoxic activity, neutrophil adhesion to endothelium, and chemotactic activity of neutrophils. Second, ketamine decreases Toll-like receptor expression, nuclear factorkB activity, and Raf/Raf cascade. Third, ketamine suppresses cytokines, superoxide, and nitric oxide productions, and reduces the mitochondrial membrane potential in macrophages. Finally, ketamine prevents the alteration of immune function in patients early after a major surgery, and increases survival in rats with sepsis .
Cerebral perfusion pressure (CPP) was compromised only in the patients with pre-existing intracranial hypertension and obstruction to the flow of cerebral spinal fluid. This has, however, led to the persistent belief that ketamine is contraindicated in patients with traumatic head injuries. Studies done subsequently have shown, however, that the effects of ketamine on cerebral haemodynamics and ICP are in fact variable and depend on both the presence of additional anaesthetic agents and PaCO2 values . Meta-analysis also suggests that Ketamine does not increase ICP and provides favorable hemodynamics . Meta analysis has shown that when ketamine is used in the presence of controlled ventilation, in conjunction with anaesthetics which reduce cerebral metabolism such as GABA receptor agonists, ICP is not increased.
The gold standard technique for ICP measurement is an intraventricular catheter[10]; however, this method is invasive and can have complications . Non-invasive ICP (nICP) measurement is a promising technique, still under development in adult and pediatric population .Optic nerve sheath diameter (ONSD) measurement using ocular ultrasonography is a safe, quick, reliable and reproducible technique for the assessment of ICP . Transcranial Doppler Ultrasonography (TCD) can also non-invasively assess ICP and CPP. Increased ICP produces characteristic changes in cerebral blood flow velocity (FV) waveform that can be assessed by decreases in the diastolic FV and increases in the pulsatility index (PI=systolic FV - diastolic FV) / mean FV) and several methods TCD derived have been proposed to assess non invasively ICP, showing good performance .
Sepsis-associated encephalopathy (SAE) usually manifests as sleep awakening cycle disturbance, cognitive impairment, delirium, and coma . Considering that brain edema secondary to SAE is one of the complications and causes of death in patients with sepsis, early detection of intracranial hypertension (ICH) is of great significance for timely intervention and improved prognosis. However, most patients with sepsis without intracranial infection have no indications for invasive intracranial pressure (ICP) monitoring; thus, non-invasive ICP monitoring was selected .
Therefore, in patients without invasive ICP monitoring, nICP methods may be useful for determining if ketamine infusion in septic patient will cause a pathological increase in ICP.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- septic patient admitted to intensive care units at zagazig university hospitals
Key inclusion criteria (4 listed)
- Patient acceptance (if conscious)
- Age >18years.
- Sex: both.
- septic patient.
Key exclusion criteria (7 listed)
- Patient refusal
- Inflammatory lesions of the optic nerve itself (optic neuritis)
- Trauma to eye like rupture globe
- Glaucoma and optic atrophy
- History of previous intracranial surgery or spinal cord disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1- To compare the ICP monitoring after ketamine infusion in septic patient
Time frame: 4 months
To evaluate ICP monitoring parameters before and after ketamine infusion in septic patient (changes in ICP parameters)
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 1 May 2023.
- Derived from this study: PubMed 40533623Negm EM, Ali HT, Nofal HA, Mosallem A, Ahmed AE, Morsy AA, Elserafy TS, Elgohary M, Altaher KM, Sharaf El Deen S, Albialy HA, Gouda AM, Beniamen A. Impact of Low-Dose Ketamine Infusion on Intracranial Pressure and Hemodynamics in Septic Shock Patients. Neurocrit Care. 2026 Feb;44(1):136-145. doi: 10.1007/s12028-025-02302-4. Epub 2025 Jun 18.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Intracranial Pressure Changes, run by Zagazig 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 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: finished, as of the sponsor's last update on 1 May 2023. 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.
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?
1- To compare the ICP monitoring after ketamine infusion in septic patient (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149586, which also lists 1 linked publication.
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 1 May 2023.