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Perioperative Fluid Management in Patients Receiving Cadaveric Renal Transplants

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01075750
First Posted: February 25, 2010
Last Update Posted: February 12, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eva Meitner, Medical University of Vienna
  Purpose

In this study we want to show that the choice of a balanced type fluid solution for the perioperative fluid management of patients receiving cadaveric renal transplantation results in less occurrence of intra- and postoperative hyperkalemia, and thus the need for postoperative dialysis. Additionally, we aim to determine whether the use of a balanced infusion solution leads to less occurrence of metabolic acidosis and electrolyte disorders than the use of isotonic saline.

Furthermore we want to evaluate whether perioperative fluid management with balanced infusion solutions results in a higher frequency of primary graft function than with administration of isotonic saline.

We will test the hypothesis that the use of "Elomel isoton"(Fresenius Kabi Austria GmbH) a balanced infusion solution will result in less occurrence of hyperkalemia and consequent post-transplant dialysis, less occurrence of metabolic acidosis, decreased incidence of electrolyte disorders and higher incidence of primary graft function when compared to isotonic saline for perioperative fluid management in patients receiving cadaveric renal transplantation.


Condition
Hyperkalaemia Requiring Postoperative Dialysis Metabolic Acidosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Perioperative Fluid Management in Patients Receiving Cadaveric Renal Transplants - Effects of Normal Saline Versus Balanced Infusates on the Incidence of Electrolyte and Acid-base Disturbances

Resource links provided by NLM:


Further study details as provided by Eva Meitner, Medical University of Vienna:

Primary Outcome Measures:
  • intra or postoperative hyperkalaemia [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • metabolic acidosis [ Time Frame: 7 days ]

Enrollment: 150
Study Start Date: June 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal Saline
Patients receiving Normal Saline during and after the renal transplantation.
Elomel Isoton
Patients receiving Elomel Isoton during and after renal transplantation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients receiving a cadaveric renal transplant in the General Hospital of Vienna
Criteria

Inclusion Criteria:

  • All patients with end-stage-renal disease admitted for cadaveric renal transplantation will be included in the study

Exclusion Criteria:

  • Patients younger than 18 years of age
  • Hyperkalemia defined as a serum potassium exceeding 5.5 mmol/L pre-operatively
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01075750


Locations
Austria
Medical University of Vienna/General Hospital of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Chair: Edith Fleischmann, Univ.Prof Medical University of Vienna
Study Director: Gregor Lindner, MD Inselspital Bern, University of Bern
Principal Investigator: Eva Meitner, MD Medical University of Vienna
Principal Investigator: Peter Biesenbach, MD Medical University of Vienna
  More Information

Responsible Party: Eva Meitner, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01075750     History of Changes
Other Study ID Numbers: MUViennaAnemev
First Submitted: February 24, 2010
First Posted: February 25, 2010
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Eva Meitner, Medical University of Vienna:
hyperkalaemia
metabolic acidosis
renal transplantation
normal saline
elomel isoton
fluid management in renal transplantation

Additional relevant MeSH terms:
Acidosis
Hyperkalemia
Acid-Base Imbalance
Metabolic Diseases
Water-Electrolyte Imbalance