| NCT ID | NCT06146270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Russian Federation of Anesthesiologists and Reanimatologists |
| Condition | Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 162,000 participants |
| Start Date | 2025-01-09 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 162,000 participants in total. It began in 2025-01-09 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Identification of risk factors that cause a high probability of an unfavorable outcome in the postoperative period is an urgent problem. The creation of national databases (registries) makes it possible to maximally cover a certain patient population by identifying its characteristic risk predictors. As literature data show, existing registries differ in the criteria for inclusion in the study, in the characteristics of the populations studied, and there is often no common view on the classification of postoperative outcomes. Goal of a study is a creation of a Russian national calculator for the risk of postoperative complications and mortality. Two-level observational retrospective-prospective study was planned. Setting: National multicenter study of surgical inpatients. Patients: Adult patients undergoing elective and emergency surgery. Types of interventions: in obstetrics, in gynecology, on the breast, in urology and kidneys, in endocrine surgery, in maxillofacial surgery, in orthopedics and traumatology, on the lower floor of the abdominal cavity, on the liver and biliary tract, on the upper floor of the abdominal cavity cavities, in thoracic surgery, in vascular surgery, in neurosurgery, in cardiac surgery, in other areas (with mandatory specification). The study was organized by the Federation of Anesthesiologists and Reanimatologists of Russia. Primary (30-day mortality, 30-day complications) and secondary (hospital mortality, hospital complications, length of stay in anesthesiology, resuscitation and intensive care departments, length of hospital stay, multiple organ failure (2 or more points on the SOFA scale (Sequential)) Organ Failure Assessment), 90-day mortality, 90-day complications, intensive care after-effects syndrome, readmission, 1-year mortality) outcomes were determined. The required sample size and statistical analysis methods are described. The planned duration of the study is 2024-2028.
Eligibility Criteria
Inclusion Criteria: * Adult patients (age 18 years and older) undergoing elective surgery: * In obstetrics * In gynecology * Breast * In urology and kidneys * In endocrine surgery * In maxillofacial surgery * In orthopedics and traumatology * On the lower abdominal cavity * On the liver and biliary tract * On the upper abdominal cavity * In thoracic surgery * In vascular surgery * In neurosurgery * In cardiac surgery * In other areas (with mandatory specification) * Adult patients (age 18 years and older) undergoing emergency surgery in the listed and other areas of surgery (for example, in purulent surgery). Exclusion Criteria: 1. Lack of informed consent from the patient 2. Complications associated with the manipulations of an anesthesiologist 3. Interventions without the participation of an anesthesiologist-resuscitator 4. Incomplete checklists 5. Errors when filling checklists 6. Deviations from the Register protocol
Contact & Investigator
Igor Zabolotskikh, MD
STUDY CHAIR
Kuban State Medical University
Frequently Asked Questions
Who can join the NCT06146270 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06146270 currently recruiting?
Yes, NCT06146270 is actively recruiting participants. Contact the research team at pobeda_zib@mail.ru for enrollment information.
Where is the NCT06146270 trial being conducted?
This trial is being conducted at Arkhangelsk, Russia, Kemerovo, Russia, Krasnodar, Russia, Krasnodar, Russia and 11 additional locations.
Who is sponsoring the NCT06146270 clinical trial?
NCT06146270 is sponsored by Russian Federation of Anesthesiologists and Reanimatologists. The principal investigator is Igor Zabolotskikh, MD at Kuban State Medical University. The trial plans to enroll 162,000 participants.