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

NCT02912299 | Completed

• 1 other identifier: NL 56729.099.16
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypernatremia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Septic patients

Patients admitted to the ICU that fulfill the criteria for the systemic inflammatory response syndrome in the presence of a(n expected) new infection. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation.

Procedure: Skin biopsies; Other: Blood and urine analysis; Other: Blood collection for RNA-investigation

CABG patients

Patients admitted to the ICU after coronary artery bypass grafting. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation.

Procedure: Skin biopsies; Other: Blood and urine analysis; Other: Blood collection for RNA-investigation

Patients before hip replacement

Patients that will undergo a hip replacement because of arthrosis. 2 3mm skin biopsies will be taken, blood and urine analysis will take place and also blood collection for RNA-investigation.

Procedure: Skin biopsies; Other: Blood and urine analysis; Other: Blood collection for RNA-investigation

Interventions

Skin biopsies PROCEDURE

2 3mm skin biopsies will be taken

CABG patients; Patients before hip replacement; Septic patients

Blood and urine analysis OTHER

Measurement of sodium, potassium and kidneyfunction in blood and urine.

CABG patients; Patients before hip replacement; Septic patients

Blood collection for RNA-investigation OTHER

A blood sample that, in case of relevant differences between groups, could be used for RNA-profiling.

CABG patients; Patients before hip replacement; Septic patients

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Frisius Medisch Centrum: lead
• University Medical Center Groningen: collaborator

Study Sites (1)

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 10397213 BACKGROUND

• 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.

  PMID: 23369520 BACKGROUND

• 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.

  PMID: 21468200 BACKGROUND

• 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.

  PMID: 12060595 BACKGROUND

• 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.

  PMID: 12888617 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Slides for microscopic investigations, containing slices of the skin biopsies. These biopsies are only diagnostic and these are specific and only for study properties. Study involvement will not influence diagnostic or therapeutic interventions that are due to common treatment.

MeSH Terms

Conditions

Hypernatremia

Interventions

Blood Specimen Collection; Urinalysis

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Christiaan Boerma, MD PhD

  medical center leeuwarden

  PRINCIPAL INVESTIGATOR

• Jaap van den Born, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 23, 2016
• Study Start: November 3, 2016
• Primary Completion: September 5, 2017
• Study Completion: September 5, 2017
• Last Updated: September 8, 2017

Record last verified: 2017-09

Locations

NL (1)