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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	31 August 2015
Main ID:	NCT02528448
Date of registration:	17/08/2015
Prospective Registration:	No
Primary sponsor:	Regional Hospital Holstebro
Public title:	0,9% NaCl Effect on Kidney Function and Glycocalyx in Patients Operated on for Primary Hiparthrosis KIPA
Scientific 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
Date of first enrolment:	March 2015
Target sample size:	40
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT02528448
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Phase:	Phase 4

Countries of recruitment
Denmark

Contacts

Name:	Andreas N Jørgensen, MD
Address:
Telephone:	78436589
Email:	andrjr@rm.dk
Affiliation:

Name:	Erling B Perdersen, MD, DMSc
Address:
Telephone:
Email:
Affiliation:	Regional Hospital Holstebro

Name:	Jesper N Bech, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Regional Hospital Holstebro

Name:	Niels Peter Ekeløf, MD, PhD
Address:
Telephone:
Email:
Affiliation:	Regional Hospital Holstebro

Key inclusion & exclusion criteria

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

Age minimum: 60 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Nephrotoxicity

Intervention(s)

Drug: 0,9% saline

Drug: Plasma-lyte

Primary Outcome(s)

Urinary excretion of Neutrophil gelatinase-associated lipocalin [Time Frame: two days]

Secondary Outcome(s)

Plasma concentration of albumin [Time Frame: two days]

Plasma concentration of brain natriuretic peptide (BNP) [Time Frame: two days]

Plasma concentration of cyclic guanosine monophosphate (cGMP) [Time Frame: two days]

Plasma concentration of potassium [Time Frame: two days]

Plasma concentration of vasopressin (AVP, ADH) [Time Frame: two days]

Plasma osmolarity [Time Frame: two days]

Plasma concentration of chloride [Time Frame: two days]

Urinary excretion of Fatty acid-binding protein [Time Frame: two days]

Free water clearance [Time Frame: two days]

plasma Syndecan-1 [Time Frame: two days]

Urinary excretion of albumin [Time Frame: two days]

Urinary excretion of chloride [Time Frame: two days]

Urinary excretion of cyclic guanosine monophosphate [Time Frame: two days]

Urinary excretion of potassium [Time Frame: two days]

middle arterial pressure [Time Frame: two days]

Plasma concentration of endothelin [Time Frame: two days]

pulse [Time Frame: two days]

Urinary excretion of creatinine [Time Frame: two days]

Plasma concentration of aldosterone [Time Frame: two days]

plasma renin concentration [Time Frame: two days]

Plasma concentration of angiotensin 2 [Time Frame: two days]

Urinary excretion of epithelial sodium channels [Time Frame: two days]

Urinary excretion of sodium-chloride symporter [Time Frame: two days]

Urinary osmolarity [Time Frame: two days]

pH [Time Frame: two days]

Plasma concentration of creatinine [Time Frame: two days]

Plasma concentration of sodium [Time Frame: two days]

Urinary excretion of Kidney Injury Molecule [Time Frame: two days]

Urinary excretion of water channels [Time Frame: two days]

Fractional urinary sodium excretion [Time Frame: two days]

Plasma concentration of atrial natriuretic peptide (ANP) [Time Frame: two days]

Urinary excretion of sodium [Time Frame: two days]

Secondary ID(s)

NPE-01-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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