An interventional study of 30 ml/Kg/h crystalloid and 10 ml/Kg/h crystalloid in Fluid Overload, sponsored by Alaa Mazy. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2018-02-12.
Sponsored by Alaa Mazy · Not applicable, Interventional, and Diagnostic
Bedside lung ultrasound can detect pulmonary congestion by detecting the appearance of B-lines. Pulmonary edema may occur even without cardiomyopathy or heart failure, especially after excessive fluid administration. B-lines have been acknowledged as sonographic signs of pulmonary interstitial and alveolar edema in critical and emergency care. Limited scientific evidence on optimal intraoperative fluid management has resulted in large variations of administered fluid regimens in daily practice. The restricted perioperative intravenous fluid regimen reduces complications after elective surgeries, however other studies had shown that intraoperative liberal fluid administration improves postoperative organ functions and recovery and shortens hospital stay after elective surgeries.
A review of patients undergoing major abdominal surgery, excluding high-risk patients, compared liberal and restrictive fluid regimens; concluded that it is difficult to define 'liberal' or 'restrictive' protocols in clinical practice. patients undergoing moderate-risk surgery seem to benefit from the more liberal fluid administration, while patients undergoing high-risk or major surgery seem to benefit from restrictive or conservative strategies. Lung ultrasound used for comparison between liberal and restrictive fluid therapy in laparoscopic hysterectomy patients by detecting the B-lines intraoperatively or immediately postoperatively. The aim is to evaluate the lung ultrasound as a guide for intraoperative fluid management, being an index for increased extravascular lung water (ECLW). This operation is a moderately complex procedure that implies the Trendelenburg position. This position - in addition to liberal fluids - will increase venous return and increase the challenge on the cardiac muscle under anesthesia in these patients.
Exclusion Criteria:
received 30 ml/Kg/h crystalloid for maximum 3 hours.
Drug: 30 ml/Kg/h crystalloid
received 10 ml /Kg/h crystalloids for maximum 3 hours.
Drug: 10 ml/Kg/h crystalloid
Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 30 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.
Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 10 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.
The rate of lung ultrasound B lines appearance.
Three or more comet lines appearance in a lung field. Two or more positive regions per side suggested a B-pattern. B -lines are defined as discrete laser-like vertical hyper-echoic artifacts that arise from the pleura line extend to the bottom of the screen without fading and move synchronously with lung sliding.
Time frame: 5 minutes after the end of surgery.
The total volume of crystalloid infusion.
milliliter
Time frame: Intraoperative.
The total volume of blood transfusion.
milliliter
Time frame: Intraoperative.
The amount of blood loss.
milliliter, estimated from the weight of swaps and suction bottles.
Time frame: Intraoperative.
The duration of surgery.
minutes. from the time of induction of anesthesia till extubation time.
Time frame: intraoperative.
Central venous pressure
centimeter water.
Time frame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Mean blood pressure
millimeter mercury.
Time frame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Heart rate.
Beats per minute.
Time frame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Peripheral oxygen saturation.
percent.
Time frame: Basal 15 minutes preoperative, intraoperative at 15, 30, 45, 60, 90, 120, 150, 180 minutes.
Hourly urine output.
milliliter,
Time frame: intraoperative,
Arterial blood gases.
for arterial oxygen and carbon dioxide tensions in millimeter mercury, base excess level in millimole per liter.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Serum sodium level.
millimole per liter.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Serum potassium level.
millimole per liter.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Hemoglobin level.
milligram per deciliter.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Hematocrit value.
percent.
Time frame: 15 minutes preoperative, 15 minutes postoperative.
Plan to share: Undecided
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Alaa Mazy