Ongoing Clinical Trials for Post Procedural Hypotension
There is currently 1 ongoing clinical trial investigating treatments for post procedural hypotension, specifically focusing on managing low blood pressure during breast reconstruction surgery. The trial is examining fluid management strategies and medication to maintain stable blood pressure during and after surgery.
Clinical trial locations
Study on Fluid Therapy and Noradrenaline for Low Blood Pressure in Breast Reconstruction Surgery Patients
This trial is investigating how to best manage low blood pressure during a specific type of breast reconstruction surgery called deep inferior epigastric perforator (DIEP) free flap surgery. During this procedure, tissue from the lower abdomen is used to rebuild the breast, and maintaining stable blood pressure is essential for the success of the transplanted tissue.
Main inclusion criteria:
- Female patients between 18 and 70 years of age
- Scheduled for DIEP free flap breast reconstruction surgery
- Able to provide signed written informed consent
Main exclusion criteria:
- Patients not experiencing low blood pressure during the surgery
- Patients outside the specified age range
- Male patients
- Patients belonging to vulnerable populations requiring special protection
Focus and goal: The study aims to understand how a treatment approach called goal-directed fluid therapy affects patient outcomes during DIEP free flap breast reconstruction. This method involves carefully controlling the amount and type of fluids given during surgery to maintain optimal blood pressure and fluid balance. Researchers will monitor how much fluid is given during surgery, the amount of blood pressure medication needed, and how well patients recover in the intensive care unit after the procedure. The study also tracks blood flow to the transplanted tissue and watches for any surgical complications.
Investigational treatments: The trial uses two main treatments. First, patients receive a balanced salt solution called Plasma-Lyte 148, which contains important minerals like magnesium, potassium, and sodium to help maintain the body’s fluid and electrolyte balance. Second, if needed, patients receive noradrenaline (also called norepinephrine), a medication that helps increase blood pressure by tightening blood vessels. The study compares how these treatments work when used as part of the goal-directed fluid therapy approach versus standard care. Additionally, phenylephrine may be used as another option to manage low blood pressure during the procedure.
Throughout the surgery and recovery, the medical team closely monitors blood pressure, measures blood lactate levels to assess tissue oxygen supply, and uses special technology called near-infrared spectroscopy to check blood flow in the transplanted tissue. Patients are carefully observed in the intensive care unit or post-anesthesia care unit after surgery until they are stable enough for discharge.
Summary
Currently, there is only one clinical trial available for post procedural hypotension, specifically targeting low blood pressure management during DIEP free flap breast reconstruction surgery. This trial is being conducted in Belgium and focuses on optimizing fluid management strategies using goal-directed therapy combined with medications like noradrenaline and phenylephrine. The study addresses an important aspect of surgical care, as maintaining stable blood pressure during this complex reconstructive procedure is crucial for successful outcomes and tissue survival. The trial’s emphasis on careful fluid monitoring and blood pressure support reflects current efforts to improve patient safety and recovery in specialized surgical procedures.