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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary: 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.
Sponsor: Medical Centre Leeuwarden

Current Primary Outcome: Difference in sodium concentration in skin biopsy between groups [ Time Frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients ]

Skin biopsies will be taken within the described time frame, analysis will take place after all biopsies of all subjects are included


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Immunohistochemistry: outcomes of proteoglycans [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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: versican (if enough tissue is available) [ Time Frame: 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: biglycan- if enough tissue is available [ Time Frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients ]
  • mRNA profiling of proteoglycans and synthesizing enzymes by way of RNA-isolation - if enough tissue is available [ Time Frame: Different for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients ]


Original Secondary Outcome: Same as current

Information By: Medical Centre Leeuwarden

Dates:
Date Received: September 13, 2016
Date Started: November 2016
Date Completion: October 2018
Last Updated: March 22, 2017
Last Verified: September 2016