NephrotoxicityPhase 4KIPANCT02528448
0,9% NaCl Effect on Kidney Function and Glycocalyx in Patients Operated on for Primary Hiparthrosis
A Phase 4 study testing Plasma-lyte and 0,9% saline in people with Nephrotoxicity, run by Regional Hospital Holstebro at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Nephrotoxicity
- What is being tested?
- Plasma-lyte and 0,9% saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for uncemented primary hiparthroplasty
- age < 60
Who cannot join
- Blooddonation or transfusion during the last month
- Not willing to participate
- estimated GFR below 30ml/min
- type 1 diabetes
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Medical Research, Regional Hospital Holstebro
Holstebro, 7500
About this study
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
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.
Read the 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
- Being tested
- Plasma-lyte, 0,9% saline
- Keywords
- Vasoactive hormones, bio markers, salt regulation, Renal variables
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma-lyteDrug
Also called ATC: B 05 BB 01
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% salineDrug
Also called sodium chloride
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: 0,9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary excretion of Neutrophil gelatinase-associated lipocalin
Measured: two days
Secondary outcomes (32)
plasma Syndecan-1
Measured: two days
plasma renin concentration
Measured: two days
Urinary excretion of cyclic guanosine monophosphate
Measured: two days
Urinary excretion of epithelial sodium channels
Measured: two days
Urinary excretion of water channels
Measured: two days
Plasma concentration of angiotensin 2
Measured: two days
Plasma concentration of aldosterone
Measured: two days
Plasma concentration of atrial natriuretic peptide (ANP)
Measured: two days
Plasma concentration of brain natriuretic peptide (BNP)
Measured: two days
Plasma concentration of cyclic guanosine monophosphate (cGMP)
Measured: two days
Plasma concentration of endothelin
Measured: two days
Plasma concentration of vasopressin (AVP, ADH)
Measured: two days
Urinary excretion of Fatty acid-binding protein
Measured: two days
Urinary excretion of Kidney Injury Molecule
Measured: two days
Free water clearance
Measured: two days
Plasma concentration of albumin
Measured: two days
Plasma concentration of chloride
Measured: two days
Plasma concentration of creatinine
Measured: two days
Plasma osmolarity
Measured: two days
Plasma concentration of sodium
Measured: two days
Plasma concentration of potassium
Measured: two days
Urinary excretion of creatinine
Measured: two days
Urinary excretion of chloride
Measured: two days
Urinary excretion of sodium
Measured: two days
Urinary excretion of potassium
Measured: two days
Fractional urinary sodium excretion
Measured: two days
Urinary osmolarity
Measured: two days
Urinary excretion of albumin
Measured: two days
Urinary excretion of sodium-chloride symporter
Measured: two days
pH
Measured: two days
pulse
Measured: two days
middle arterial pressure
Measured: two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrotoxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regional Hospital Holstebro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erling Bjerregaard Pedersen, Regional Hospital Holstebro
- Investigators
- Jesper N Bech, MD, PhD, Principal investigator, Regional Hospital HolstebroErling B Perdersen, MD, DMSc, Study director, Regional Hospital HolstebroNiels Peter Ekeløf, MD, PhD, Principal investigator, Regional Hospital Holstebro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528448
- Sponsor's protocol ID
- NPE-01-2014
- Acronym
- KIPA
- Status last verified
- Aug 2015
- First submitted
- 17 Aug 2015
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33771116
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02528448
- Acronym / sponsor ID
- KIPA / NPE-01-2014
- Conditions
- Nephrotoxicity
- Keywords
- Vasoactive hormones, bio markers, salt regulation, Renal variables
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Regional Hospital HolstebroUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 19 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| plasma-lyte | Active comparator | Drug: Plasma-lyteContinuous 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 | Active comparator | Drug: 0,9% salineContinuous 1 hour infusion of 0,9% saline15 micrograms/kg/hour for the first hour then 5 micrograms/kg/hour + amount needet for blood replacement |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for uncemented primary hiparthroplasty
- age < 60
Key exclusion criteria (4 listed)
- Blooddonation or transfusion during the last month
- Not willing to participate
- estimated GFR below 30ml/min
- type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma-lyteAlso: ATC: B 05 BB 01Continuous 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% salineAlso: sodium chlorideContinuous 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 | Drug | 0,9% saline |
Primary outcome
Urinary excretion of Neutrophil gelatinase-associated lipocalin
Time frame: two days
32 secondary outcomes
plasma Syndecan-1
Time frame: two days
plasma renin concentration
Time frame: two days
Urinary excretion of cyclic guanosine monophosphate
Time frame: two days
Urinary excretion of epithelial sodium channels
Time frame: two days
Urinary excretion of water channels
Time frame: two days
Plasma concentration of angiotensin 2
Time frame: two days
Plasma concentration of aldosterone
Time frame: two days
Plasma concentration of atrial natriuretic peptide (ANP)
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 endothelin
Time frame: two days
Plasma concentration of vasopressin (AVP, ADH)
Time frame: two days
Urinary excretion of Fatty acid-binding protein
Time frame: two days
Urinary excretion of Kidney Injury Molecule
Time frame: two days
Free water clearance
Time frame: two days
Plasma concentration of albumin
Time frame: two days
Plasma concentration of chloride
Time frame: two days
Plasma concentration of creatinine
Time frame: two days
Plasma osmolarity
Time frame: two days
Plasma concentration of sodium
Time frame: two days
Plasma concentration of potassium
Time frame: two days
Urinary excretion of creatinine
Time frame: two days
Urinary excretion of chloride
Time frame: two days
Urinary excretion of sodium
Time frame: two days
Urinary excretion of potassium
Time frame: two days
Fractional urinary sodium excretion
Time frame: two days
Urinary osmolarity
Time frame: two days
Urinary excretion of albumin
Time frame: two days
Urinary excretion of sodium-chloride symporter
Time frame: two days
pH
Time frame: two days
pulse
Time frame: two days
middle arterial pressure
Time frame: two days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Derived from this study: PubMed 33771116Ostergaard 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.
Related trials for Nephrotoxicity
Recruiting
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
Renal Cancer, Renal Secondary Cancer
Not yet recruitingObservational study
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
Biomarkers, Acute Kidney Injury
Enrolling by invitation
Rutin and Ascorbic Acid for Prevention of Vancomycin-Induced Nephrotoxicity in Adult Patients" - a Clinical Trial Protocol Evaluating Whether Combined Rutin/Vitamin C Supplementation Reduces Kidney Toxicity From Vancomycin, Compared to Vitamin C Alone and Control.
Nephrotoxicity, Acute Kidney Injuries
Not yet recruitingPhase 1
Safety Study of GMDTC Injection in Participants With Solid Tumors and Cisplatin-Induced Renal Dysfunction
Cisplatin Nephrotoxicity, Cisplatin Adverse Reaction
Active, not recruitingPhase 3
Cisplatin Disposition and Kidney Injury
Nephrotoxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesper N Bech, MD, PhD principal investigator
Regional Hospital Holstebro
Erling B Perdersen, MD, DMSc study director
Regional Hospital Holstebro
Niels Peter Ekeløf, MD, PhD principal investigator
Regional Hospital Holstebro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Plasma-lyte and 0,9% saline in people with Nephrotoxicity, run by Regional Hospital Holstebro at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas N Jørgensen, MD (78436589, andrjr@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary excretion of Neutrophil gelatinase-associated lipocalin (time frame: two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02528448, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.