Investigation on Differences in Skin Sodium Content Between Normal Subjects and ICU-patients

Hypernatremia Clinical Trial

— InCa  

Official title:

Onderzoek Naar Intracutane Natriumopslag Bij Intensive Care patiënten (InCa-studie)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02912299
• Other study ID #: NL 56729.099.16
• Status: Completed
• Phase: N/A
• First received: September 13, 2016
• Last updated: September 5, 2017
• Start date: November 3, 2016
• Est. completion date: September 5, 2017

Study information

• Verified date: September 2017
• Source: Medical Centre Leeuwarden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 5, 2017
• Est. primary completion date: September 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypernatremia

Intervention

Procedure:
• Skin biopsies
2 3mm skin biopsies will be taken

Other:
• Blood and urine analysis
Measurement of sodium, potassium and kidneyfunction in blood and urine.
• Blood collection for RNA-investigation
A blood sample that, in case of relevant differences between groups, could be used for RNA-profiling.

Locations

Country	Name	City	State
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden

Sponsors (2)

Lead Sponsor	Collaborator
Medical Centre Leeuwarden	University Medical Center Groningen

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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. — View 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. — View 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. — View 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. Epub 2003 Jul 29. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in sodium concentration in skin biopsy between groups	Skin biopsies will be taken within the described time frame, analysis will take place after all biopsies of all subjects are included	Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary	Immunohistochemistry: outcomes of proteoglycans		Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary	Immunohistochemistry: binding capacity of proteoglycans		Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary	Immunohistochemistry: density of lymph capillaries		Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary	Immunohistochemistry: presence of macrophage influx		Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary	Quantification of different matrix components / proteoglycans: decorine - if enough tissue is available		Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary	Quantification of different matrix components / proteoglycans: versican (if enough tissue is available)		Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary	Quantification of different matrix components / proteoglycans: biglycan- if enough tissue is available		Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Secondary	mRNA profiling of proteoglycans and synthesizing enzymes by way of RNA-isolation - if enough tissue is available		Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients