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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma-lyte | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary excretion of Neutrophil gelatinase-associated lipocalin | two days |
| Measure | Description | Time Frame |
|---|---|---|
| plasma Syndecan-1 | two days | |
| plasma renin concentration | two days | |
| Urinary excretion of cyclic guanosine monophosphate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andreas N Jørgensen, MD | Contact | 78436589 | andrjr@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Research, Regional Hospital Holstebro | Recruiting | Holstebro | 7500 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33771116 | Derived | 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. |
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| ID | Term |
|---|---|
| C012499 | Plasma-lyte 148 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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|
| 0,9% saline | 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 |
|
|
| two days |
| Urinary excretion of epithelial sodium channels | two days |
| Urinary excretion of water channels | two days |
| Plasma concentration of angiotensin 2 | two days |
| Plasma concentration of aldosterone | two days |
| Plasma concentration of atrial natriuretic peptide (ANP) | two days |
| Plasma concentration of brain natriuretic peptide (BNP) | two days |
| Plasma concentration of cyclic guanosine monophosphate (cGMP) | two days |
| Plasma concentration of endothelin | two days |
| Plasma concentration of vasopressin (AVP, ADH) | two days |
| Urinary excretion of Fatty acid-binding protein | two days |
| Urinary excretion of Kidney Injury Molecule | two days |
| Free water clearance | two days |
| Plasma concentration of albumin | two days |
| Plasma concentration of chloride | two days |
| Plasma concentration of creatinine | two days |
| Plasma osmolarity | two days |
| Plasma concentration of sodium | two days |
| Plasma concentration of potassium | two days |
| Urinary excretion of creatinine | two days |
| Urinary excretion of chloride | two days |
| Urinary excretion of sodium | two days |
| Urinary excretion of potassium | two days |
| Fractional urinary sodium excretion | two days |
| Urinary osmolarity | two days |
| Urinary excretion of albumin | two days |
| Urinary excretion of sodium-chloride symporter | two days |
| pH | two days |
| pulse | two days |
| middle arterial pressure | two days |
| Regional Hospital Holstebro |
| Principal Investigator |
| D017670 |
| Sodium Compounds |