AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Egypt1 site
  • Zagazig university

    Zagazig

Other trials in Egypt

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted8 Dec 2021
  2. Study start10 Dec 2021
  3. Primary completion10 Mar 2023
  4. Study completion20 Mar 2023

Resources

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)
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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in