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

NCT ID: NCT02528448

Last Updated: 2015-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2016-02-29

Brief 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.

Detailed 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.

Conditions

Nephrotoxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Plasma-lyte

Intervention Type: DRUG

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% saline15 micrograms/kg/hour for the first hour then 5 micrograms/kg/hour + amount needet for blood replacement

Group Type: ACTIVE_COMPARATOR

0,9% saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

ATC: B 05 BB 01; sodium chloride

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regional Hospital Holstebro

OTHER

Sponsor Role: lead

Responsible Party

Erling Bjerregaard Pedersen

Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jesper N Bech, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Regional Hospital Holstebro

Erling B Perdersen, MD, DMSc

Role: STUDY_DIRECTOR

Regional Hospital Holstebro

Niels Peter Ekeløf, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Regional Hospital Holstebro

Locations

Department of Medical Research, Regional Hospital Holstebro

Holstebro, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Andreas N Jørgensen, MD

Role: CONTACT

andrjr@rm.dk

78436589

References

Ostergaard AM, Jorgensen AN, Bovling S, Ekelof NP, Mose FH, Bech JN. Effect of 0.9% NaCl compared to plasma-lyte on biomarkers of kidney injury, sodium excretion and tubular transport proteins in patients undergoing primary uncemented hip replacement - a randomized trial. BMC Nephrol. 2021 Mar 26;22(1):111. doi: 10.1186/s12882-021-02310-4.

Reference Type: DERIVED

PMID: 33771116 (View on PubMed)

Other Identifiers

NPE-01-2014

Identifier Type: -

Identifier Source: org_study_id