NCT02528448

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

11 months

First QC Date

August 17, 2015

Last Update Submit

August 18, 2015

Conditions

Nephrotoxicity

Keywords

Vasoactive hormonesbio markerssalt regulationRenal variables

Outcome Measures

Primary Outcomes (1)

  • Urinary excretion of Neutrophil gelatinase-associated lipocalin

    two days

Secondary Outcomes (32)

  • plasma Syndecan-1

    two days

  • plasma renin concentration

    two days

  • Urinary excretion of cyclic guanosine monophosphate

    two days

  • Urinary excretion of epithelial sodium channels

    two days

  • Urinary excretion of water channels

    two days

  • +27 more secondary outcomes

Study Arms (2)

plasma-lyte

ACTIVE COMPARATOR

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

Drug: Plasma-lyte

0,9% saline

ACTIVE COMPARATOR

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

Drug: 0,9% saline

Interventions

Plasma-lyteDRUG

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

Also known as: ATC: B 05 BB 01
plasma-lyte
0,9% salineDRUG

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

Also known as: sodium chloride
0,9% saline

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Indication for uncemented primary hiparthroplasty
  • age \< 60

You may not qualify if:

  • Blooddonation or transfusion during the last month
  • Not willing to participate
  • estimated GFR below 30ml/min
  • type 1 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Regional Hospital Holstebro

Holstebro, 7500, Denmark

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33771116DERIVED

MeSH Terms

Interventions

Plasma-lyte 148Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jesper N Bech, MD, PhD

    Regional Hospital Holstebro

    PRINCIPAL INVESTIGATOR

  • Erling B Perdersen, MD, DMSc

    Regional Hospital Holstebro

    STUDY DIRECTOR

  • Niels Peter Ekeløf, MD, PhD

    Regional Hospital Holstebro

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas N Jørgensen, MD

CONTACT

78436589andrjr@rm.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD

Study Record Dates

First Submitted

August 17, 2015

First Posted

August 19, 2015

Study Start

March 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

DK(1)