Perioperative Fluid Management in Patients Receiving Cadaveric Renal Transplants
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ClinicalTrials.gov Identifier: NCT01075750 |
Recruitment Status :
Completed
First Posted : February 25, 2010
Last Update Posted : February 12, 2013
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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 or disease |
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Hyperkalaemia Requiring Postoperative Dialysis Metabolic Acidosis |

Study Type : | Observational |
Actual Enrollment : | 150 participants |
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 |
Study Start Date : | June 2010 |
Actual Primary Completion Date : | February 2013 |
Actual Study Completion Date : | February 2013 |

Group/Cohort |
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Normal Saline
Patients receiving Normal Saline during and after the renal transplantation.
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Elomel Isoton
Patients receiving Elomel Isoton during and after renal transplantation
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- intra or postoperative hyperkalaemia [ Time Frame: 7 days ]
- metabolic acidosis [ Time Frame: 7 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

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
Austria | |
Medical University of Vienna/General Hospital of Vienna | |
Vienna, Austria, 1090 |
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 |
Responsible Party: | Eva Meitner, M.D., Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT01075750 |
Other Study ID Numbers: |
MUViennaAnemev |
First Posted: | February 25, 2010 Key Record Dates |
Last Update Posted: | February 12, 2013 |
Last Verified: | February 2013 |
hyperkalaemia metabolic acidosis renal transplantation |
normal saline elomel isoton fluid management in renal transplantation |
Acidosis Hyperkalemia Acid-Base Imbalance Metabolic Diseases Water-Electrolyte Imbalance |