Study on Fluid Therapy and Noradrenaline for Low Blood Pressure in Breast Reconstruction Surgery Patients

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What is this study about?

This clinical trial is focused on studying arterial hypotension, which is a condition where blood pressure is lower than normal, during a specific type of breast reconstruction surgery known as deep inferior epigastric perforator (DIEP) free flap surgery. The study will explore the effects of a treatment approach called goal-directed fluid therapy, which involves carefully managing the fluids given to patients during surgery to maintain optimal blood pressure and fluid balance.

Two treatments will be used in this study. The first is a solution called Plasma-Lyte® 148 (pH 7.4) solution for infusion, which contains a mix of important salts and minerals like magnesium chloride hexahydrate, potassium chloride, sodium chloride, sodium acetate trihydrate, and sodium gluconate. These substances help maintain the body’s fluid and electrolyte balance. The second treatment is a medication called noradrenaline (norepinephrine) 1 mg/ml concentrate for solution for infusion, which is used to help increase blood pressure by narrowing blood vessels.

The purpose of the study is to investigate how this fluid management strategy affects the amount of fluid given during surgery and its impact on the patient’s recovery. Participants will receive either the treatment or a placebo during their surgery. The study will monitor various factors, such as the total amount of fluid given during surgery, the amount of noradrenaline used, and the patient’s blood pressure and recovery in the intensive care unit. The study aims to provide valuable insights into improving care for patients undergoing DIEP free flap breast reconstruction.

1 joining the study

Participation begins after signing a written informed consent form.

Eligibility includes being a female adult between 18 and 70 years of age, scheduled for DIEP free flap breast reconstruction.

2 preparation for surgery

Before surgery, preparations are made for the procedure, which involves deep inferior epigastric perforator (DIEP) free flap breast reconstruction.

3 surgery and fluid management

During surgery, a solution called Plasma-Lyte® 148 is administered through an intravenous infusion to manage fluid levels.

The goal is to control fluid administration effectively throughout the operation.

4 use of norepinephrine

If necessary, norepinephrine is given intravenously to manage blood pressure during and after surgery.

The dosage is adjusted based on the patient’s needs to maintain stable blood pressure.

5 postoperative monitoring

After surgery, monitoring continues in the intensive care unit (ICU) or post-anesthesia care unit (PACU).

Blood lactate levels are checked hourly during surgery and every four hours in the ICU until discharge.

The percentage of time the systolic blood pressure (SBP) is above 100mmHg is recorded.

6 free flap perfusion monitoring

Postoperative free flap perfusion is monitored using near-infrared spectroscopy (NIRS) during the ICU/PACU stay.

7 assessment of surgical outcomes

Surgical complications, such as flap loss or hematoma, are assessed at ICU/PACU discharge and at hospital discharge.

8 discharge and follow-up

The length of stay in the ICU/PACU is recorded in hours.

Discharge from the hospital occurs after ensuring stable recovery and monitoring results.

Who Can Join the Study?

Female adult patients, between 18 and 70 years of age
Patients scheduled for DIEP free flap breast reconstruction (a type of surgery to rebuild the breast using tissue from the lower belly)
Signed written informed consent form (a document that explains the study and confirms the patient’s agreement to participate)

Who Cannot Join the Study?

Patients who are not experiencing arterial hypotension during the specific type of breast reconstruction surgery called DIEP free flap. Arterial hypotension means having low blood pressure in the arteries.
Patients who are not within the specified age range for the study.
Patients who are not female, as the study is only for female participants.
Patients who belong to a vulnerable population, which means groups that might need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Az Maria Middelares Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	09.10.2023

Trial locations

Investigated drugs:

Goal-directed Fluid Therapy is a method used to manage the amount of fluids given to a patient during surgery. In this trial, it is being used during breast reconstruction surgery to ensure that the patient receives the right amount of fluids. This approach aims to improve the patient’s recovery by optimizing fluid levels, which can help maintain blood pressure and reduce complications.

Arterial Hypotension during Deep Inferior Epigastric Perforator (DIEP) Free Flap Breast Reconstruction – This condition involves a drop in blood pressure that occurs during a specific type of breast reconstruction surgery known as DIEP free flap. The procedure uses tissue from the lower abdomen to reconstruct the breast, and maintaining stable blood pressure is crucial for the success of the surgery. Arterial hypotension can lead to inadequate blood flow to the transplanted tissue, potentially affecting its viability. The condition is managed by carefully monitoring and adjusting fluid levels and medications during the operation. It is important to ensure that blood pressure remains within a safe range to support the healing process. This condition is not classified as a rare disease.

Trial ID:

2023-506152-24-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Fluid Therapy and Noradrenaline for Low Blood Pressure in Breast Reconstruction Surgery Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?