Dal-PROTECT is a completed Phase 3 trial of Dalargin, a synthetic leucine-enkephalin analogue, in 200 patients having high-risk abdominal surgery. ClinicalTrials.gov lists completion on September 10, 2026, and no posted results as of October 25, 2026. The study tested whether perioperative treatment reduced major postoperative complications.
Key takeaways
- NCT07404358 records a randomized, placebo-controlled Phase 3 trial at Botkin Hospital in Moscow, with 200 actual participants.
- The primary endpoint was at least one of four major complications within seven days: cardiac injury, acute kidney injury, acute respiratory distress syndrome or sepsis.
- The registered 35% placebo and 20% Dalargin event rates were sample-size assumptions; observed group results are still awaited.
- Original papers trace Dalargin to Soviet peptide research and describe earlier animal, cell and small clinical studies.
In this article
On September 10, 2026, the Dal-PROTECT trial reached its listed completion date. The ClinicalTrials.gov record for NCT07404358 lists the study as completed, with 200 participants actually enrolled and a last update posted September 23, 2026. As of October 25, 2026, it has no posted results.
What the registry says now
| Field | Registry entry |
|---|---|
| Registry ID | NCT07404358; protocol BOTKIN-DAL-PROTECT-01 |
| Sponsor and site | Botkin Hospital; S.P. Botkin Moscow Multidisciplinary Scientific and Clinical Center, Moscow |
| Status | Completed |
| Phase | Phase 3 |
| Design | Interventional, randomized, parallel assignment, placebo-controlled |
| Masking | Official title: double-blind. Structured record: four masked roles—participant, care provider, investigator and outcomes assessor. |
| Enrollment | 200 actual |
| Start | May 13, 2025 (actual) |
| Primary completion | September 10, 2026 (actual) |
| Study completion | September 10, 2026 (actual) |
| First posted | February 11, 2026 |
| Last update posted | September 23, 2026 |
| Results | None posted as of October 25, 2026 |
What Dalargin is
Dalargin is a synthetic hexapeptide: Tyr-D-Ala-Gly-Phe-Leu-Arg. It is a leucine-enkephalin analogue, with glycine at position 2 replaced by D-alanine and an arginine added at position 6. The D-alanine helps resist peptidases; a 1999 tissue-bioassay study found it potent and selective at μ-opioid receptors (British Journal of Pharmacology).
A 1985 paper from the USSR Cardiology Research Center describes Dalargin as a new drug developed from leucine-enkephalin and reports cytoprotection in rat ulcer and liver-injury models (PubMed). That paper described mainly delta-receptor binding, whereas the 1999 assays favored μ receptors. These findings come from different experimental systems; Dal-PROTECT investigates the clinical organ-protection hypothesis.
From Soviet peptide to surgical trial
A 1990 Khirurgiia report described a Dalargin-containing anesthetic technique in 36 abdominal-surgery patients, reporting reduced intraoperative narcotic use and changes in liver-enzyme, malondialdehyde and hemodynamic measurements (PubMed). Its small comparison series examined physiological and biochemical outcomes, rather than the organ-complication composite registered for Dal-PROTECT.
A 2023 cell study found delta-opioid-dependent protection against cold-stress apoptosis in L929 fibroblasts (PubMed). Together with the earlier rat experiments, it supplies laboratory evidence about cellular responses; the clinical question concerns postoperative complications in people.
Why high-risk abdominal surgery
The trial’s eligibility criteria specified adults scheduled for elective high-risk abdominal surgery—gastrectomy, pancreatectomy, colectomy—under general anesthesia. The hypothesis is that perioperative Dalargin reduces ischemia-reperfusion injury, oxidative stress, and systemic inflammation enough to lower organ dysfunction. The registry describes this proposed mechanism as pharmacological preconditioning. The primary endpoint measures cardiac injury, acute kidney injury, respiratory distress or sepsis after surgery.
Eligibility is 18 to 85, ASA I-III, written consent. Exclusions include ASA IV-V, myocardial infarction or stroke in the past six months, NYHA class IV heart failure, chronic kidney disease stage 3a or higher, active infection, diagnosed psychiatric or neuromuscular disease, pregnancy or breastfeeding, and prior enrollment.
The trial design
Dal-PROTECT is two-arm, parallel-group. The registered protocol assigns participants 1:1 to perioperative Dalargin or a matching saline placebo. The comparison tests whether treatment lowers the registered complication rate.
The primary endpoint, component by component
The primary outcome is major postoperative complications: at least one of four events within seven days after surgery.
- MINS: elevated high-sensitivity cardiac troponin T with an ischemic feature; symptoms not required.
- AKI: KDIGO criteria.
- ARDS: Berlin definition.
- Sepsis: Sepsis-3 criteria.
A composite counts a patient once if any component occurs and does not weight severity. A significant result could be driven by one component while others move little. The component breakdown will matter as much as the headline proportion.
The registry also lists ARDS, AKI and sepsis individually as secondary outcomes. A future report can be checked against this registered primary composite and its component definitions.
Other secondary outcomes include interleukin-6 and procalcitonin at 24 hours, ICU and hospital stay up to 30 days, 30-day mortality, postoperative delirium, malondialdehyde at two days, and HOMA-IR at five days.
The sample-size assumptions are not results
The registry explains how 200 was chosen. Investigators assumed a 35% composite event rate on placebo and 20% on Dalargin—a 15-percentage-point absolute difference. With two-sided alpha 0.05, 80% power, and a chi-squared test, they calculated 178 participants, then planned for about 10% dropout and rounded to 200.
Those percentages are planning assumptions used to size the trial. The registry posts no observed event rate for either group and no treatment-effect estimate.
Registration timing and the evidence trail
The record was first submitted February 5, 2026, and first posted February 11, 2026, about nine months after the listed May 13, 2025 study start.
The protocol ID BOTKIN-DAL-PROTECT-01 and ethics approval EC #6/25/5 can help track a future publication.
What to look for next
The useful next evidence is a results module or trial report with event counts for each group, an effect estimate and confidence interval, the individual complications, and adverse events. Those figures would show how the groups compared on the registered outcome.
How we checked
The ClinicalTrials.gov page and API record were fetched October 25, 2026. The API reported hasResults false, COMPLETED, actual enrollment 200, Phase 3, and the dates above. PubMed, Europe PMC, Crossref, and OpenAlex were queried the same day for Dalargin, Dal-PROTECT, NCT07404358, and Botkin Hospital; no linked publication or results paper was found.
The history and experimental findings above come from the cited original papers. The publication search was bounded to those databases and queries on October 25, 2026; it did not cover every conference proceeding or non-indexed publication.
FAQs
Is the Dal-PROTECT trial finished?
Yes. ClinicalTrials.gov lists NCT07404358 as completed on September 10, 2026, with the last update posted September 23, 2026.
Did Dalargin work?
No treatment-effect result is available in the registry as of October 25, 2026. The dated publication searches described here identified no linked Dal-PROTECT outcome report.
What was the primary endpoint?
A composite of major postoperative complications within seven days: MINS, AKI by KDIGO, ARDS by the Berlin definition, or sepsis by Sepsis-3. At least one event counts.
Sources
- ClinicalTrials.gov. Dalargin for Prevention of Organ Disfunction in High-Risk Abdominal Surgery (Dal-PROTECT). NCT07404358. Record and API fetched October 25, 2026.
- ClinicalTrials.gov API v2 record for NCT07404358.
- British Journal of Pharmacology. Activity profiles of dalargin and its analogues in μ-, δ- and κ-opioid receptor selective bioassays. 1999.
- Bulletin of the USSR Cardiology Research Center. Dalargin--a peptide preparation with cytoprotective action. 1985.
- Khirurgiia. Use of dalargin in complex anesthesiological protection during operations on the abdominal organs. 1990.
- Cryo Letters. Effect of dalargin on apoptosis of L929 fibroblasts during cold stress. 2023.
This article explains a clinical trial and the published research behind it. It is for general information and is not medical advice.