Nephrotoxicity Clinical Trial
Official title:
The Effect of 0,9% NaCl on the Kidney Function, Vasoactive Hormones, Biomarkers and Glycosaminglycanes in Plasma in Patients Operated on for Primary Hiparthrosis
The purpose of this study is to determine if chloride is nephrotoxic using 0,9% saline versus Plasma-Lytein in patients having primary hip replacement surgery. The outcome is found measuring bio markers, vasoactive hormones and salt regulation. And to measure syndecan as a marker for glycocalyx degradation.
Hypothesis:
Chloride has a nephrotoxic effect, which can be shown partially by measuring bio markers for
tubular injury in urine, partially by the changes in tubular transport of sodium and water
in different parts of the nephron. This can be demonstrated using isotone sodium solutions
with a lower chloride concentration in this study plasma-lyte versus normal isotone saline.
Klorid has a toxic effect on the glycocalyx layer and leads to a rise in syndecan 1 and
simultaneously a change in Salt Blood Test either by a direct simulation and ANP levels in
plasma or as a consequence of the hyperchloremic acidosis. This can be demonstrated using
isotone sodium solutions with a lower chloride concentration in this study plasma-lyte
versus normal isotone saline.
Purpose:
The purpose is to observe changes in bio markers, vasoactive hormones and salt regulation in
patients randomized to either 0,9% saline or plasma-lyte undergoing primary uncemented hip
replacement surgery.
Design:
40 patients undergoing primary uncemented hip replacement surgery will be randomized to
either 0,9% saline or plasma-lyte for standard fluid resuscitation and blood loss
replacement in this controlled and double blinded study. The patients will deliver a 24 hour
urine sample before surgery and approximately 10 days after. From the start of the surgery
and to the day after all urine will be collected and blood samples will be taken.
Perspective:
If chloride is found to be nephrotoxic it could lead to a general change in fluid
resuscitation recommendations in critically ill patient, patients with kidney disease and
patients undergoing surgery. It will also expand our knowledge about the permeability of the
blood vessels.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
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