Ongoing Clinical Trials for Post Procedural Hypotension
Currently, there is 1 ongoing clinical trial investigating post procedural hypotension. This trial focuses on managing low blood pressure that occurs during breast reconstruction surgery, specifically examining how fluid therapy and medication can help maintain stable blood pressure during and after the procedure.
Clinical trial locations
Study on Fluid Therapy and Noradrenaline for Low Blood Pressure in Breast Reconstruction Surgery Patients
This clinical trial is investigating how to better manage low blood pressure that can occur during a specific type of breast reconstruction surgery called deep inferior epigastric perforator (DIEP) free flap surgery. The procedure uses tissue from the lower abdomen to rebuild the breast, and maintaining stable blood pressure throughout the operation is crucial for the success of the transplanted tissue.
Who can participate:
- Female adults between 18 and 70 years of age
- Patients scheduled for DIEP free flap breast reconstruction surgery
- Those who have signed a written informed consent form agreeing to participate in the study
Who cannot participate:
- Patients not experiencing low blood pressure during the surgery
- Individuals outside the specified age range
- Male patients, as the study is designed specifically for females
- Members of vulnerable populations who may require special protection or care
What the trial involves:
The study examines a treatment approach called goal-directed fluid therapy, which involves carefully managing the fluids given to patients during surgery. Participants will receive a fluid solution called Plasma-Lyte 148, which contains important salts and minerals such as magnesium chloride, potassium chloride, sodium chloride, sodium acetate, and sodium gluconate. These substances help maintain the body’s fluid and electrolyte balance.
If needed, patients may also receive noradrenaline (also called norepinephrine), a medication that helps increase blood pressure by narrowing blood vessels. The dosage is adjusted based on each patient’s individual needs to keep blood pressure stable throughout the procedure.
During and after surgery, medical staff will closely monitor several factors, including the total amount of fluid given, blood pressure levels, and blood lactate levels. After surgery, patients are monitored in the intensive care unit or post-anesthesia care unit. The transplanted tissue is also monitored using near-infrared spectroscopy to ensure adequate blood flow. Any surgical complications, such as tissue loss or bleeding, are carefully assessed both at discharge from intensive care and when leaving the hospital.
Purpose of the trial:
The main goal is to understand how this careful fluid management strategy affects the amount of fluid needed during surgery and how it impacts patient recovery. Researchers want to determine whether this approach can improve outcomes for patients undergoing this complex reconstructive procedure by maintaining optimal blood pressure and tissue perfusion throughout the operation and recovery period.
Summary
There is currently one active clinical trial for post procedural hypotension, located in Belgium. This trial specifically targets low blood pressure occurring during DIEP free flap breast reconstruction surgery. The study focuses on optimizing fluid management using goal-directed therapy with Plasma-Lyte 148 solution and, when necessary, noradrenaline to maintain stable blood pressure. The trial is designed exclusively for female patients aged 18 to 70 undergoing this specific type of reconstructive surgery. The research aims to improve understanding of how careful fluid and medication management during surgery can support better patient outcomes and recovery.