0,9% NaCl Effect on Kidney Function and Glycocalyx in Patients Operated on for Primary Hiparthrosis

Last updated: August 18, 2015
Sponsor: Regional Hospital Holstebro
Overall Status: Trial Status Unknown

Phase

4

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT02528448
NPE-01-2014
  • Ages > 60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Indication for uncemented primary hiparthroplasty

  • age < 60

Exclusion

Exclusion Criteria:

  • Blooddonation or transfusion during the last month

  • Not willing to participate

  • estimated GFR below 30ml/min

  • type 1 diabetes

Study Design

Total Participants: 40
Study Start date:
March 01, 2015
Estimated Completion Date:
February 29, 2016

Study Description

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.

Connect with a study center

  • Department of Medical Research, Regional Hospital Holstebro

    Holstebro, 7500
    Denmark

    Active - Recruiting

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