An interventional study of 5% human plasma protein fraction (PPF) in Coagulation; Intravascular and Fluid Electrolyte Disorders, sponsored by Hamad Medical Corporation. Status unknown at 1 site in Qatar. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-05.
Sponsored by Hamad Medical Corporation · Not applicable, Interventional, and Supportive care
Evaluation of acid-base and electrolyte changes after administration of commonly used colloid solutions (plasma protein fraction contains 5% albumin), and crystalloids (saline 0.9% and lactated ringers solutions) is the primary endpoint of this study. The secondary endpoints are to study dilution acidosis and changes in plasma volume induced by albumin versus crystalloids and their effect on tissue perfusion by randomizing patients into two groups where each group receives intraoperatively one type of the two fluids. Changes in acid-base, electrolytes, and dilution acidosis
To compare Between PPF 5% and crystalloids in the management of patients undergoing Liver resection and to conclude if any the benefits of treating those patients with high protein content fluids.
Methodology: Each patient will complete a full medical and surgical history and clinical examination.
Routine examinations will include complete blood picture, kidney function tests (serum urea, creatinine, sodium, and potassium), liver function tests (alanine transaminase, aspartate transaminase, prothrombin time and concentration and international normalized ratio, and serum albumin), random blood sugar, and serum electrolytes (Calcium, Chloride bicarbonate and lactate). Patients will be distributed randomly between two groups using a predetermined computer-generated randomized schedule. Twenty-four of the 48 patients will receive an intraoperative intravenous infusion of 5% human plasma protein fraction PPF, (A group). PPF 5%?Octapharma 5 %? is a colloid solution containing (47.6-52.5% proteins, of which 45.6-52.5 gm/L albumin and 142.5-157.5 mmol/L sodium). The remaining 24 patients will receive an intraoperative intravenous infusion of crystalloids (0.9 % normal saline and/ or Lactated Ringer's solution) (RS group). Fluids will be given targeting euvolemic state which is defined as central venous pressure (CVP) 5-10 mmHg or Stroke volume variation (SVV) of? 13%. Central venous pressure (CVP) CVP of -1 to 1 mmHg or Stroke volume variation (SVV) of 18-21% (12) will be targeted during transaction times.
The transfusion trigger will be Hemoglobin of? 8 gm/dl. Any patient who received additional blood products will be excluded from the study. General anesthesia will be induced using Propofol 2% and fentanyl. The ultrasound-guided central venous catheter will be inserted after induction of anesthesia in the right internal jugular vein. Arterial Cather size 20-gauge will be inserted in the radial artery. All patients will receive inhalational anesthesia using Sevoflurane, targeting MAC 1, and be ventilated using the Drager Xeus machine. Tidal volume of 7ml/Kg and zero PEEP will be used for all patients. All patients will receive furosemide 20-40 mg to maintain good diuresis and control central venous pressure. In addition to this, a 30-45 degree head-up position will be maintained. Arterial blood will be drawn through the radial artery catheter before the start of surgery and fluid infusion (time 0), the start of liver resection (time R), after Liver resection (time AR), and at the end of the procedure (time E). Arterial blood gas parameters (using atrial blood gas analyzer machine) including, pH, K+, Cl-, HCO3-, base deficit, and lactate concentrations will be measured. Hemoglobin, hematocrit concentrations, and albumin will be measured and recorded at time 0, R, AR \& E. Intravascular albumin mass will be calculated based on plasma volume (PV) which will be calculated according to Nadler's Formula for calculating total blood volume in adult (TBV) (9, 14): PV = TBV ? (1 ? hematocrit)
Hamad Medical Corporation is the lead sponsor of 133 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Twenty-four of the 48 patients will receive an intraoperative intravenous infusion of 5% human plasma protein fraction PPF, (A group). PPF 5% "Octapharma 5 %" is a colloid solution containing (47.6-52.5% proteins, of which 45.6-52.5 gm/L albumin and 142.5-157.5 mmol/L sodium). Fluids will be given targeting euvolemic state which is defined as central venous pressure (CVP) 5-10 mmHg or Stroke volume variation (SVV) of ≤ 13%. Central venous pressure (CVP) CVP of -1 to 1 mmHg or Stroke volume variation (SVV) of 18-21% (12) will be targeted during transaction times. The transfusion trigger will be Hemoglobin of ≤8 gm/dl.
Drug: 5% human plasma protein fraction (PPF)
24 patients will receive an intraoperative intravenous infusion of crystalloids (0.9 % normal saline and/ or Lactated Ringer's solution) (RS group). Fluids will be given targeting euvolemic state which is defined as central venous pressure (CVP) 5-10 mmHg or Stroke volume variation (SVV) of ≤ 13%. Central venous pressure (CVP) CVP of -1 to 1 mmHg or Stroke volume variation (SVV) of 18-21% (12) will be targeted during transaction times. The transfusion trigger will be Hemoglobin of ≤8 gm/dl.
Infusion of 5% human plasma protein fraction PPF. PPF 5% "Octapharma 5 %" is a colloid solution containing (47.6-52.5% proteins, of which 45.6-52.5 gm/L albumin and 142.5-157.5 mmol/L sodium).
Also known as: 5% Human Albumen
Base deficit
The primary end point of the study will be changes in base deficit in the two groups
Time frame: Intra-operative at the end of the four stages of liver resection
Strong Ion difference
The primary end point of the study will be changes in strong ion difference in the two groups
Time frame: Intra-operative time at the end of four stages of liver resection
Intra-vascular Albumin content
The primary end point of the study will be changes in intra-vascular albumin mass in the two groups
Time frame: Intra-operative time at the end of the four stages of liver resection
Kidney functions
Two group comparison on postoperative serum creatinine and urine output at the end of surgery
Time frame: Urine out put at the end of surgery and postoperative day one serum creatinine
Total blood loss
Comparing the two groups regarding intra-operative blood loss
Time frame: End of surgery blood loss
Changes in coagulation using Thromboelastogram
Comparing the coagulation of the two groups at the end of resection and end of surgery
Time frame: At the the end of resection phase and end of surgery
Tissue perfusion index
statistically comparing tissue perfusion index between the two groups at the 4 surgical times
Time frame: The four intra-operative stages of liver resection
Plan to share: Yes — A decision regarding sharing information will be taken at later stage
Supporting information: Study protocol, Sap, Icf
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Hamad Medical Corporation