Perioperative Fluid Therapy With Balanced Crystalloids

Acid Base Imbalance Clinical Trial

Official title:

Perioperative Fluid Therapy With Balanced Crystalloids: a Comparative Randomized Prospective Open Label Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02691676
• Other study ID #: GV29125 16/14
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2016
• Last updated: May 8, 2017
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: May 2017
• Source: University Hospital Olomouc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Introduction: The strategy of perioperative fluid therapy has an important impact not only on the circulating volume and perfusion of organs and tissues but also on the patient's internal environment. The study aimed at comparing the effects of perioperatively administered balanced crystalloid infusion solutions containing different amounts of metabolizable anions on homeostasis.

Methods: In the prospective randomized study, patients were assigned to Plasmalyte (PL) and Ringerfundin (RF) Groups after their postoperative transfer to an intensive care unit (ICU). The infusion solutions were parenterally administered at 1000 mL/6 hours. Arterialized capillary blood was sampled at the time of transfer to the ICU (Time 0), and again at 2 hours and 6 hours from Time 0. The collected blood was tested for blood gas parameters using the Astrup method.

Description:

Study design

The study was designed as a single-center, randomized, prospective study and approved by the University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc ethics committee. It comprised patients over 18 years of age undergoing surgery at the hospital's Department of Surgery I and subsequently placed in an ICU bed. As there were no limitations concerning the type of procedures, these involved a wide range of abdominal and thoracic surgeries; however, all of them were elective procedures. No patients were critically ill, being classified as ASA III or less.

Sample collection and processing To determine the present status of the internal environment, arterialized capillary blood was drawn from the fingertip at the time of patients' transfer from the operating room to the ICU (Time 0), and again at 2 hours and 6 hours from Time 0. The collected blood was tested in the laboratory using the Astrup method to measure the following parameters: pH, BE, actual bicarbonate (aBi), standard bicarbonate (sBi), partial pressure of oxygen (pO2) and carbon dioxide (pCO2). The obtained values were entered into a table and statistically analyzed. Both patients groups were adjusted for age and length of surgery to allow their comparison.

Infusion solutions

The following infusion solutions were parenterally administered using a central or, more frequently, peripheral venous catheter:

1. Plasmalyte in 5% glucose infusion solution (PL), manufactured by Baxter Healthcare as slightly alkalizing (Na+ 140; K+ 5.0; Mg2+ 1.5; Cl- 98; acetate 27; gluconate 23) and

2. Ringerfundin infusion solution (RF), manufactured by B. Braun as acid-base neutral (Na+ 145; K+ 4.0; Mg2+ 1.0; Ca2+ 2.5; Cl- 127; acetate 24; malate 5.0).

At the time of their transfer to the ICU, patients were randomized into PL and RF Groups. Parenteral administration of the two solutions was initiated immediately after collection of the first blood sample at 166 mL/hour. Thus, all patients received 1000 mL of infusion solution over 6 hours. Patients requiring more rapid fluid replacement due to postoperative hypovolemia were excluded from the study. Patients were routinely rewarmed with a warm air blanket and received humidified oxygen via a face mask or, in case of good oxygenation, via a nasal cannula.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age 18+

• elective surgery procedures

Exclusion Criteria:

• critically ill, being classified as ASA III or less

• surgery longer than 6 hrs

• hypersensitivity to PL or RF

• requiring more rapid fluid replacement (than 1000 ml/6 hrs) due to postoperative hypovolemia

Related Conditions & MeSH terms

• Acid Base Imbalance
• Acid-Base Imbalance

Intervention

Drug:
• Plasmalyte
Parenteral administration of Plasmalyte initiated immediately after collection of the first blood sample at 166 mL/hour. Thus, all patients received 1000 mL of infusion solution over 6 hours.
• Ringerfundin
Parenteral administration of Ringerfundin initiated immediately after collection of the first blood sample at 166 mL/hour. Thus, all patients received 1000 mL of infusion solution over 6 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Olomouc

References & Publications (13)

Bouchard J, Mehta RL. Fluid balance issues in the critically ill patient. Contrib Nephrol. 2010;164:69-78. doi: 10.1159/000313722. Epub 2010 Apr 20. Review. — View Citation

Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. Review. — View Citation

Chowdhury AH, Cox EF, Francis ST, Lobo DN. A randomized, controlled, double-blind crossover study on the effects of 1-L infusions of 6% hydroxyethyl starch suspended in 0.9% saline (voluven) and a balanced solution (Plasma Volume Redibag) on blood volume, — View Citation

Holte K, Jensen P, Kehlet H. Physiologic effects of intravenous fluid administration in healthy volunteers. Anesth Analg. 2003 May;96(5):1504-9, table of contents. — View Citation

Holte K, Klarskov B, Christensen DS, Lund C, Nielsen KG, Bie P, Kehlet H. Liberal versus restrictive fluid administration to improve recovery after laparoscopic cholecystectomy: a randomized, double-blind study. Ann Surg. 2004 Nov;240(5):892-9. — View Citation

Kirkendol PL, Starrs J, Gonzalez FM. The effects of acetate, lactate, succinate and gluconate on plasma pH and electrolytes in dogs. Trans Am Soc Artif Intern Organs. 1980;26:323-7. — View Citation

Kocián P, Neumann J, Majtan P, Hoch J. [Fluid therapy and surgical outcomes after low anterior resection]. Rozhl Chir. 2014 Sep;93(9):463-7. Czech. — View Citation

Lowell JA, Schifferdecker C, Driscoll DF, Benotti PN, Bistrian BR. Postoperative fluid overload: not a benign problem. Crit Care Med. 1990 Jul;18(7):728-33. — View Citation

Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005 Jul;103(1):25-32. — View Citation

Rahbari NN, Zimmermann JB, Schmidt T, Koch M, Weigand MA, Weitz J. Meta-analysis of standard, restrictive and supplemental fluid administration in colorectal surgery. Br J Surg. 2009 Apr;96(4):331-41. doi: 10.1002/bjs.6552. Review. — View Citation

Simmons RS, Berdine GG, Seidenfeld JJ, Prihoda TJ, Harris GD, Smith JD, Gilbert TJ, Mota E, Johanson WG Jr. Fluid balance and the adult respiratory distress syndrome. Am Rev Respir Dis. 1987 Apr;135(4):924-9. — View Citation

Zadák Z, Hyspler R, Hronek M, Tichá A. The energetic and metabolic effect of Ringerfundin (B. Braun) infusion and comparison with Plasma-Lyte (Baxter) in healthy volunteers. Acta Medica (Hradec Kralove). 2010;53(3):131-7. — View Citation

Zavorsky GS, Cao J, Mayo NE, Gabbay R, Murias JM. Arterial versus capillary blood gases: a meta-analysis. Respir Physiol Neurobiol. 2007 Mar 15;155(3):268-79. Epub 2006 Aug 17. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with significant acid basic disturbances related to balanced alkalizing as compared with a balanced pH-neutral crystalloids.	The internal environment status is assessed at the time of patients' transfer from the operating room to the ICU (Time 0), and again at 6 hours from Time 0. Outcome over a longer period of time is not rated.	6 hours