Dalargin for Prevention of Organ Disfunction in High-Risk Abdominal Surgery

Plain-language summary

This study evaluates the drug Dalargin, compared with saline (0.9% NaCl), for preventing organ dysfunction in patients undergoing high-risk abdominal surgery. Patients aged 18 to 85 scheduled for elective high-risk abdominal surgery under general anesthesia can take part. The study is being conducted in Phase 3; it is active but not currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Active, not recruiting

Sponsor

Botkin Hospital

Intervention

Dalargin, 0.9 % NaCl

Start date

5/13/2025

Estimated completion

12/20/2026

Countries

Russia

Related genes

Locations

• Moscow, Russia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Male or female patients aged 18 to 85 years.
* Scheduled for elective high-risk abdominal surgery (e.g., gastrectome, pancreatectomy, colectomy) under general anesthesia.
* American Society of Anesthesiologists (ASA) physical status class I-III.
* Able to provide written informed consent.

Exclusion Criteria:

* ASA physical status class IV or V.
* Acute myocardial infarction within the past 6 month.
* Acute stroke within the past 6 month.
* Chronic heart failure NYHA class IV.
* Chronic kidney disease stage 3a or higher (according KDIGO)
* Active infectious disease.
* Any diagnosed phychiatric disorder (according ICD-10) confirmed be a psychiatrist.
* Any neuromuscular disease (according to ICD-10)
* Pregnancy or breastfeeding.
* Inability to undergo preoperative assessment.
* Previous enrollment in this trial.