Published February 11, 2026. A regulatory style news brief reports on a registered clinical trial evaluating Dalargin as a preventive measure against organ dysfunction in patients undergoing abdominal surgery who are at high risk. The study record lists the conditions as postoperative complications and multiple organ failure and identifies the interventions as Dalargin and 0.9 percent saline. Botkin Hospital is named as the sponsor. The trial status is active but not recruiting, indicating no current enrollment plans. This update is relevant for regulatory affairs professionals, trial sponsors, and clinicians tracking experimental therapies in surgical care. The document provides a concise view of how this trial fits into ongoing efforts to assess new interventions in a surgical population and highlights the need to follow official records for enrollment changes and results.
What changed in the trial status?
The trial record shows an active status with no current recruitment. The study identifier is NCT07404358. Botkin Hospital is listed as the sponsor. The intervention includes the drug Dalargin and saline 0.9 percent as co interventions, with the conditions of postoperative complications and risk of organ failure in abdominal surgery scenarios. The official record is accessible on ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07404358?term=medical+device. Regular updates may follow if recruitment resumes or new results are posted.
What are the trial details?
This entry describes a drug based investigation using Dalargin. Interventions listed are Dalargin and 0.9 percent saline. The conditions include postoperative complications and multiple organ failure in abdominal surgery settings. The sponsor is Botkin Hospital. The study status is active but not recruiting. The trial record serves as a regulatory data point for tracking the development of this intervention and can be used to compare with other trials in the same clinical area. For the formal record see the ClinicalTrials.gov page above.
What are the regulatory implications?
From a regulatory perspective this record follows standard disclosure for a registered clinical trial. The designation active not recruiting indicates that recruitment activities are currently paused. The description of interventions clarifies what is being evaluated and what control or comparator is used. Any manufacturer claims would be labeled accordingly in line with MDR Annex XIV guidance and the official sponsor statements must be verified in the trial record. Stakeholders should plan for forthcoming updates to the trial status and any amendments to the protocol or consent materials.
What are safety and ethics considerations?
The available record does not provide trial outcomes or safety data. It implies ethical oversight since the trial exists in ClinicalTrials.gov. Stakeholders should await official results or status changes for updates on patient safety or adverse events. Regulatory teams should monitor for notices about safety assessments, protocol changes or safety reporting obligations as the study progresses.
Conclusion and implications
In summary this is a registered trial at Botkin Hospital evaluating Dalargin in a high risk abdominal surgery population. The study status is active but not recruiting, and 0.9 percent saline is listed as an intervention. Regulatory affairs professionals should monitor for enrollment updates, protocol amendments and eventual results releases via the official trial record. The information in the record supports ongoing regulatory tracking and communication with stakeholders who may consider the potential clinical context of this intervention.
FAQ
- 1. What is the purpose of the trial?
The record shows the trial is evaluating the drug Dalargin as part of a study in patients undergoing abdominal surgery with postoperative complications and risk of organ failure.
- 2. Who is sponsoring the study?
The sponsor listed is Botkin Hospital.
- 3. What interventions are used?
Dalargin and saline 0.9 percent are listed as interventions in this study.
- 4. What is the current recruitment status?
The entry indicates the study is active but not recruiting.
Disclaimer
Disclaimer: This content is for professional reference only. It is not legal advice. Always consult the official regulatory texts and the trial record for precise information.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07404358?term=medical+device