Perioperative Fluid Therapy With Balanced Crystalloids

NCT02691676 | Completed Phase 3

• 1 other identifier: GV29125 16/14
• Study Type: interventional
• Target: 112
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acid Base Imbalance

Keywords

crystalloids, fluid therapy, Plasmalyte, Ringerfundin

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Plasmalyte

EXPERIMENTAL

Arm 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)

Drug: Plasmalyte

Ringerfundin

ACTIVE COMPARATOR

Arm 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).

Drug: Ringerfundin

Interventions

Plasmalyte DRUG

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.

Also known as: Plasmalyte (Baxter Healthcare)

Plasmalyte

Ringerfundin DRUG

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.

Also known as: Ringerfundin (B. Braun)

Ringerfundin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18+
• elective surgery procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Olomouc: lead

Related Publications (13)

• Zadak Z, Hyspler R, Hronek M, Ticha 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. doi: 10.14712/18059694.2016.72.

  PMID: 21171525 BACKGROUND

• 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. No abstract available.

  PMID: 7245507 BACKGROUND

• 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. doi: 10.1016/j.resp.2006.07.002. Epub 2006 Aug 17.

  PMID: 16919507 BACKGROUND

• 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. doi: 10.1097/00003246-199007000-00010.

  PMID: 2364713 BACKGROUND

• Holte K, Jensen P, Kehlet H. Physiologic effects of intravenous fluid administration in healthy volunteers. Anesth Analg. 2003 May;96(5):1504-1509. doi: 10.1213/01.ANE.0000055820.56129.EE.

  PMID: 12707158 BACKGROUND

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

  PMID: 20427995 BACKGROUND

• 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. doi: 10.1164/arrd.1987.135.4.924.

  PMID: 3565940 BACKGROUND

• 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.

  PMID: 19283742 BACKGROUND

• Kocian 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.

  PMID: 25301345 BACKGROUND

• Brandstrup B. Fluid therapy for the surgical patient. Best Pract Res Clin Anaesthesiol. 2006 Jun;20(2):265-83. doi: 10.1016/j.bpa.2005.10.007.

  PMID: 16850777 BACKGROUND

• 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. doi: 10.1097/00000542-200507000-00008.

  PMID: 15983453 BACKGROUND

• 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. doi: 10.1097/01.sla.0000143269.96649.3b.

  PMID: 15492573 BACKGROUND

• 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, renal blood flow velocity, and renal cortical tissue perfusion in healthy volunteers. Ann Surg. 2014 May;259(5):881-7. doi: 10.1097/SLA.0000000000000324.

  PMID: 24253140 RESULT

MeSH Terms

Conditions

Acid-Base Imbalance

Interventions

Plasmalyte A; Ringerfundin

Condition Hierarchy (Ancestors)

Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Radovan Uvizl

  University Hospital Olomouc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radovan Uvizl, MD, Ph.D.

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 25, 2016
• Study Start: January 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share