Perioperative Fluid Management in Patients Receiving Cadaveric Renal Transplants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eva Meitner, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01075750
First received: February 24, 2010
Last updated: February 10, 2013
Last verified: February 2013
  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 Medical University of Vienna:

Primary Outcome Measures:
  • intra or postoperative hyperkalaemia [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • metabolic acidosis [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Eva Meitner, M.D., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01075750     History of Changes
Other Study ID Numbers: MUViennaAnemev
Study First Received: February 24, 2010
Last Updated: February 10, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by 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

ClinicalTrials.gov processed this record on August 20, 2014