BridgeMD
New treatment option for Brain Injuries
Official title Ketamine Infusion as a Method of Cerebral Protection in Children
ClinicalTrials.gov ID: NCT06525584
What this study is testing
What is Ketamine Hcl 50Mg/Ml Inj?
Ketamine Hcl 50Mg/Ml Inj is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain injuries.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 5
You may be able to join if
- 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
You likely can't join if
- 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;
See the full eligibility criteria
- 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
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kemerovo, Please Select, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 5 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kemerovo, Please Select, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.