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

Completed

• Conditions: Hypernatremia

• Registration Number: NCT02912299
• Lead Sponsor: Medical Centre Leeuwarden

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.

Study Timeline

• Study First Submitted: 2016-09-13
• Study First Submitted QC: 2016-09-20
• Study First Posted: 2016-09-23
• Study Start: 2016-11-03
• Status Verified: 2017-09
• Primary Completion: 2017-09-05
• Study Completion: 2017-09-05
• Last Update Submitted: 2017-09-05
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in sodium concentration in skin biopsy between groups	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

Secondary Outcome Measures

Name	Time	Method
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: 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
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
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
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
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
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
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

Trial Locations

Locations (1)

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands