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

Nephrotoxicity Clinical Trial

— KIPA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02528448
• Other study ID #: NPE-01-2014
• Status: Recruiting
• Phase: Phase 4
• First received: August 17, 2015
• Last updated: August 18, 2015
• Start date: March 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2015
• Source: Regional Hospital Holstebro
• Contact: Andreas N Jørgensen, MD
• Phone: 78436589
• Email: andrjr[@]rm.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Indication for uncemented primary hiparthroplasty

• age < 60

Exclusion Criteria:

• Blooddonation or transfusion during the last month

• Not willing to participate

• estimated GFR below 30ml/min

• type 1 diabetes

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nephrotoxicity

Intervention

Drug:
• Plasma-lyte
Continuous 1 hour infusion of plasma-lyte 15 micrograms/kg/hour for the first hour then 5 micrograms/kg/hour + amount needet for blood replacement
• 0,9% saline
Continuous 1 hour infusion of 0,9% saline 15 micrograms/kg/hour for the first hour then 5 micrograms/kg/hour + amount needet for blood replacement

Locations

Country	Name	City	State
Denmark	Department of Medical Research, Regional Hospital Holstebro	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital Holstebro

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary excretion of Neutrophil gelatinase-associated lipocalin		two days	No
Secondary	plasma Syndecan-1		two days	No
Secondary	plasma renin concentration		two days	No
Secondary	Urinary excretion of cyclic guanosine monophosphate		two days	No
Secondary	Urinary excretion of epithelial sodium channels		two days	No
Secondary	Urinary excretion of water channels		two days	No
Secondary	Plasma concentration of angiotensin 2		two days	No
Secondary	Plasma concentration of aldosterone		two days	No
Secondary	Plasma concentration of atrial natriuretic peptide (ANP)		two days	No
Secondary	Plasma concentration of brain natriuretic peptide (BNP)		two days	No
Secondary	Plasma concentration of cyclic guanosine monophosphate (cGMP)		two days	No
Secondary	Plasma concentration of endothelin		two days	No
Secondary	Plasma concentration of vasopressin (AVP, ADH)		two days	No
Secondary	Urinary excretion of Fatty acid-binding protein		two days	No
Secondary	Urinary excretion of Kidney Injury Molecule		two days	No
Secondary	Free water clearance		two days	No
Secondary	Plasma concentration of albumin		two days	No
Secondary	Plasma concentration of chloride		two days	No
Secondary	Plasma concentration of creatinine		two days	No
Secondary	Plasma osmolarity		two days	No
Secondary	Plasma concentration of sodium		two days	No
Secondary	Plasma concentration of potassium		two days	No
Secondary	Urinary excretion of creatinine		two days	No
Secondary	Urinary excretion of chloride		two days	No
Secondary	Urinary excretion of sodium		two days	No
Secondary	Urinary excretion of potassium		two days	No
Secondary	Fractional urinary sodium excretion		two days	No
Secondary	Urinary osmolarity		two days	No
Secondary	Urinary excretion of albumin		two days	No
Secondary	Urinary excretion of sodium-chloride symporter		two days	No
Secondary	pH		two days	No
Secondary	pulse		two days	No
Secondary	middle arterial pressure		two days	No