Brain InjuriesNCT06525584
Ketamine Infusion as a Method of Cerebral Protection in Children
A study testing Ketamine Hcl 50Mg/Ml Inj in people with Brain Injuries, run by Kemerovo State Medical University at 1 site in Russia.
Trial summary
The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children. Read more about this study
- Who is it for?
- Ages 1 month to 5 years
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Ketamine Hcl 50Mg/Ml Inj
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 196 participants
- Where
- 1 siteRussia
- Study dates
- 5 Nov 2023to 30 Dec 2028
- Phase
- Interventional
- 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 1 month to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age from 1 to 60 months
- body weight from 3.5 to 20 kg
- planned surgical intervention to correct a congenital heart defect (atrial or ventricular septal defect) with CPBё
- the presence of informed consent for participation in the study signed by the child's legal representative
Who cannot join
- lack of informed consent of the patient and parents to participate in the study,
- emergency and urgent surgical interventions;
- the presence of clinically significant anemia;
- hypo-thermic during operation, episodes of desaturation in the perioperative period;
- the presence of another congenital heart diseases besides the atrial or ventricular septal defect, as well as their combination;
- a history of central nervous system diseases;
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- an installed pacemaker;
- hemodynamic instability requiring preoperative pharmacological and/or mechanical support;
- any episodes of cerebrovascular accidents in the history or periop-erative period;
- the presence of a patient with severe concomitant diseases that worsen mental and somatic conditio;
- acute infection and exacerbation of chronic infection in the perioperative period;
- concomitant autoimmune diseases;
- the presence of malignant neoplasms;
- surgical complications in the postoperative period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Artem Ivkin
Kemerovo, Please Select, 650066
Artem Ivkin, +79030701880, ivkiaa@kemcardio.ru
About this study
Official title: Ketamine Infusion in the Postoperative Period as a Method of Cerebral Protection in Children During Surgical Correction of Congenital Heart Defects
The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children.
Read the detailed description
The study will examine the safety and effectiveness for neuroprotection of subanesthetic doses of ketamine in the postoperative period in children undergoing operations to correct septal congenital heart defects using cardiopulmonary bypass.
- Conditions
- Brain Injuries
- Being tested
- Ketamine Hcl 50Mg/Ml Inj, Control
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine Hcl 50Mg/Ml InjDrug
ketamine infusion at a dose of 0.1 mg/kg/hour for 16 hours
Ketamine Hcl 50Mg/Ml InjDrug
ketamine infusion at a dose of 0.3 mg/kg/hour for 16 hours
ControlOther
Without ketamine
| Study group | Role | What they receive |
|---|---|---|
| Ketamine 1 | Experimental | Not described Receives: Drug: Ketamine Hcl 50Mg/Ml Inj |
| Ketamine 3 | Experimental | Not described Receives: Drug: Ketamine Hcl 50Mg/Ml Inj |
| Control | Placebo comparator | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers
monitoring the concentration of markers of brain damage at several control points
Measured: 16 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start5 Nov 2023
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kemerovo State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Evgeny Grigoryev, Kemerovo State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525584
- Sponsor's protocol ID
- 5
- Status last verified
- Aug 2026
- First submitted
- 24 Jul 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine Infusion in the Postoperative Period as a Method of Cerebral Protection in Children During Surgical Correction of Congenital Heart Defects
- ClinicalTrials.gov ID
- NCT06525584
- Acronym / sponsor ID
- 5
- Conditions
- Brain Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Kemerovo State Medical UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 29 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.
The study is devoted to the use of ketamine infusion in a subanesthetic dose in the postoperative period in children after surgical correction of congenital heart defects in children.
Detailed description
The study will examine the safety and effectiveness for neuroprotection of subanesthetic doses of ketamine in the postoperative period in children undergoing operations to correct septal congenital heart defects using cardiopulmonary bypass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ketamine 1 | Experimental | Drug: Ketamine Hcl 50Mg/Ml Inj |
| Ketamine 3 | Experimental | Drug: Ketamine Hcl 50Mg/Ml Inj |
| Control | Placebo comparator | Other: Control |
Who may qualify
- Ages
- 1 month to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age from 1 to 60 months
- body weight from 3.5 to 20 kg
- planned surgical intervention to correct a congenital heart defect (atrial or ventricular septal defect) with CPBё
- the presence of informed consent for participation in the study signed by the child's legal representative
Key exclusion criteria (14 listed)
- lack of informed consent of the patient and parents to participate in the study,
- emergency and urgent surgical interventions;
- the presence of clinically significant anemia;
- hypo-thermic during operation, episodes of desaturation in the perioperative period;
- the presence of another congenital heart diseases besides the atrial or ventricular septal defect, as well as their combination;
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 |
|---|---|---|
| Ketamine Hcl 50Mg/Ml Injketamine infusion at a dose of 0.1 mg/kg/hour for 16 hours | Drug | Ketamine 1 |
| Ketamine Hcl 50Mg/Ml Injketamine infusion at a dose of 0.3 mg/kg/hour for 16 hours | Drug | Ketamine 3 |
| ControlWithout ketamine | Other | Control |
Primary outcome
Biomarkers
Time frame: 16 hours after operation
monitoring the concentration of markers of brain damage at several control points
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 17 Aug 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine Hcl 50Mg/Ml Inj in people with Brain Injuries, run by Kemerovo State Medical University at 1 site in Russia.
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 14 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 17 Aug 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 Russia. 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. Some participants in this study may receive a placebo. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers (time frame: 16 hours after operation). 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 17 Aug 2026.