Effect of Human Plasma Protein Transfusion With and Without Crystalloids During Major Liver Resection Surgeries

Coagulation; Intravascular Clinical Trial

Official title:

Effect of Human Plasma Protein Transfusion With and Without Crystalloids on Acid Base, Electrolytes and Tissue Perfusion During Major Liver Resection Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05033704
• Other study ID #: MRC-01-18-256
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2019
• Est. completion date: September 1, 2021

Study information

• Verified date: July 2021
• Source: Hamad Medical Corporation
• Contact: yasser Hammad, M.D.
• Phone: +97433000198
• Email: yhammad[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18- 70 years old

• Not allergic to PPF5%, NS and RL,

• No morphological or functional cardiac valve/s changes, cardiac ischemia, significant arrhythmias or in failure,

• Patients with normal liver function tests before surgery and has no chronic active liver disease,

• Patients with normal kidney functions.

Exclusion Criteria:

• Patients with cardiac disease,

• Kidney disease,

• Liver dysfunction,

• Those who receive additional blood products other than PRBCs.

Related Conditions & MeSH terms

• Coagulation; Intravascular
• Fluid Electrolyte Disorders

Intervention

Drug:
• 5% human plasma protein fraction (PPF)
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).

Locations

Country	Name	City	State
Qatar	Hamad Medical Corporation	Doha	Ad Dawhah

Sponsors (1)

Lead Sponsor	Collaborator
Hamad Medical Corporation

Country where clinical trial is conducted

Qatar, 

References & Publications (15)

Ashraf S. Hasanin, Fatma M.A. Mahmoud, Hossam M. Soliman. Factors affecting acid base status during hepatectomy in cirrhotic patients. Egyptian Journal of Anesthesia (2013) 29, 305-310).

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Dunki-Jacobs EM, Philips P, Scoggins CR, McMasters KM, Martin RC 2nd. Stroke volume variation in hepatic resection: a replacement for standard central venous pressure monitoring. Ann Surg Oncol. 2014 Feb;21(2):473-8. doi: 10.1245/s10434-013-3323-9. Epub 2 — View Citation

Goodkin DA, Raja RM, Saven A. Dilutional acidosis. South Med J. 1990 Mar;83(3):354-5. — View Citation

Greasley L, Russell RJ. Albumin and its role in trauma resuscitation. J R Army Med Corps. 2005 Jun;151(2):65-8. Review. — View Citation

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Liumbruno GM, Bennardello F, Lattanzio A, Piccoli P, Rossettias G; Italian Society of Transfusion Medicine and Immunohaematology (SIMTI). Recommendations for the use of albumin and immunoglobulins. Blood Transfus. 2009 Jul;7(3):216-34. doi: 10.2450/2009.0 — View Citation

Mathes DD, Morell RC, Rohr MS. Dilutional acidosis: is it a real clinical entity? Anesthesiology. 1997 Feb;86(2):501-3. — View Citation

Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. — View Citation

Norberg Å, Rooyackers O, Segersvärd R, Wernerman J. Leakage of albumin in major abdominal surgery. Crit Care. 2016 Apr 26;20(1):113. doi: 10.1186/s13054-016-1283-8. — View Citation

Peters T Jr. Serum albumin. Adv Protein Chem. 1985;37:161-245. Review. — View Citation

Pusey C, Dash C, Garrett M, Gascoigne E, Gesinde M, Gillanders K, Wallington T. Experience of using human albumin solution 4.5% in 1195 therapeutic plasma exchange procedures. Transfus Med. 2010 Aug 1;20(4):244-9. doi: 10.1111/j.1365-3148.2010.00999.x. Ep — View Citation

Quinlan GJ, Martin GS, Evans TW. Albumin: biochemical properties and therapeutic potential. Hepatology. 2005 Jun;41(6):1211-9. Review. — View Citation

Semin Thromb Hemost 1980; 6(2): 85-120 DOI: 10.1055/s-2007-1005097

Tullis JL. Albumin. 1. Background and use. JAMA. 1977 Jan 24;237(4):355-60 CONTD. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Base deficit	The primary end point of the study will be changes in base deficit in the two groups	Intra-operative at the end of the four stages of liver resection
Primary	Strong Ion difference	The primary end point of the study will be changes in strong ion difference in the two groups	Intra-operative time at the end of four stages of liver resection
Primary	Intra-vascular Albumin content	The primary end point of the study will be changes in intra-vascular albumin mass in the two groups	Intra-operative time at the end of the four stages of liver resection
Secondary	Kidney functions	Two group comparison on postoperative serum creatinine and urine output at the end of surgery	Urine out put at the end of surgery and postoperative day one serum creatinine
Secondary	Total blood loss	Comparing the two groups regarding intra-operative blood loss	End of surgery blood loss
Secondary	Changes in coagulation using Thromboelastogram	Comparing the coagulation of the two groups at the end of resection and end of surgery	At the the end of resection phase and end of surgery
Secondary	Tissue perfusion index	statistically comparing tissue perfusion index between the two groups at the 4 surgical times	The four intra-operative stages of liver resection