Clinical trial NCT02912299: Investigation on Differences in Skin Sodium Content Between Normal Subjects and ICU-patients
Official title: Onderzoek Naar Intracutane Natriumopslag Bij Intensive Care patiënten (InCa-studie)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypernatremia
Lead sponsor: Frisius Medisch Centrum
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2016-09-23
Enrollment: 45
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 15 patients admitted to the ICU with systemic inflammatory response syndrom in the presence of a(n expected) new infection
* 15 patients admitted to the ICU after coronary artery bypass surgery, matched by gender and age (+/- 10 years) to the septic patients
* 15 patients undergoing a hip replacement for arthrosis, matched by gender and age (+/- 10 years) to the septic patients

Brief summary: This study investigates the differens in sodium storage in skin between normal subjects, patients after cardiac surgery and septic patients.

Detailed description: According to the current paradigm ICU-acquired hypernatremia is mainly an iatrogenic problem, caused by sodium overload or water deficit. In spite of several interventions to reduce sodium intake and optimize fluid balance, critically ill patients still develop hypernatremia. These patients also seem to have an inability to excrete sodium, hence develop a positive sodium balance. In animals sodium storage in the third compartment was found. Our hypothesis is that sodium storage in the third compartment is different in critically ill patients and this difference could play a role in the development of ICU-acquired hypernatremia.

Eligibility criteria: Inclusion Criteria:

* 50-80 years (septic patients), 45-85 years (CABG and hip replacement-patients)
* Patients undergoing hip replacement: no relevant medical history (i.e. chronic and/or systemic diseases with a suspected influence on sodium / sodium handling)
* Septic patients: fulfilling the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection

Exclusion Criteria:

* Absence of both upper legs
* Skin disease that makes skin biopsies in healthy skin impossible
* Subjects with in their history formation of exaggerated scar tissue
* Subjects suffering from psoriasis or lichen ruber
* Use of skin corticosteroids on all skin of both upper legs \< 2 weeks before inclusion
* Tattoos covering the whole surface of both upper legs
* Use of diuretics in the past month
* Current renal replacement therapy
* Septic patients: not being sedated
* Patients undergoing hip replacement: hip replacement because of an inflammatory disease

Primary outcomes:
measure: Difference in sodium concentration in skin biopsy between groups
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary outcomes:
measure: Immunohistochemistry: outcomes of proteoglycans
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
measure: Immunohistochemistry: binding capacity of proteoglycans
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
measure: Immunohistochemistry: density of lymph capillaries
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
measure: Immunohistochemistry: presence of macrophage influx
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
measure: Quantification of different matrix components / proteoglycans: decorine - if enough tissue is available
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
measure: Quantification of different matrix components / proteoglycans: versican (if enough tissue is available)
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
measure: Quantification of different matrix components / proteoglycans: biglycan- if enough tissue is available
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
measure: mRNA profiling of proteoglycans and synthesizing enzymes by way of RNA-isolation - if enough tissue is available
timeFrame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Other outcomes:
Locations:
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
Study officials:
affiliation: medical center leeuwarden
name: Christiaan Boerma, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Jaap van den Born, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polderman KH, Schreuder WO, Strack van Schijndel RJ, Thijs LG. Hypernatremia in the intensive care unit: an indicator of quality of care? Crit Care Med. 1999 Jun;27(6):1105-8. doi: 10.1097/00003246-199906000-00029.
citation: Waite MD, Fuhrman SA, Badawi O, Zuckerman IH, Franey CS. Intensive care unit-acquired hypernatremia is an independent predictor of increased mortality and length of stay. J Crit Care. 2013 Aug;28(4):405-12. doi: 10.1016/j.jcrc.2012.11.013. Epub 2013 Jan 29.
citation: Lee JW. Fluid and electrolyte disturbances in critically ill patients. Electrolyte Blood Press. 2010 Dec;8(2):72-81. doi: 10.5049/EBP.2010.8.2.72. Epub 2010 Dec 31.
citation: Titze J, Krause H, Hecht H, Dietsch P, Rittweger J, Lang R, Kirsch KA, Hilgers KF. Reduced osmotically inactive Na storage capacity and hypertension in the Dahl model. Am J Physiol Renal Physiol. 2002 Jul;283(1):F134-41. doi: 10.1152/ajprenal.00323.2001.
citation: Titze J, Lang R, Ilies C, Schwind KH, Kirsch KA, Dietsch P, Luft FC, Hilgers KF. Osmotically inactive skin Na+ storage in rats. Am J Physiol Renal Physiol. 2003 Dec;285(6):F1108-17. doi: 10.1152/ajprenal.00200.2003. Epub 2003 Jul 29.