Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02912299
Acronym
InCa
Enrollment
45
Registered
2016-09-23
Start date
2016-11-03
Completion date
2017-09-05
Last updated
2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypernatremia

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.

Interventions

PROCEDURESkin biopsies

2 3mm skin biopsies will be taken

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

OTHERBlood collection for RNA-investigation

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

Sponsors

University Medical Center Groningen
CollaboratorOTHER
Frisius Medisch Centrum
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Difference in sodium concentration in skin biopsy between groupsDifferent for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patientsSkin biopsies will be taken within the described time frame, analysis will take place after all biopsies of all subjects are included

Secondary

MeasureTime frame
Immunohistochemistry: binding capacity of proteoglycansDifferent 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 capillariesDifferent 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 influxDifferent for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients
Immunohistochemistry: outcomes of proteoglycansDifferent 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
Quantification of different matrix components / proteoglycans: biglycan- if enough tissue is availableDifferent 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 availableDifferent 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 availableDifferent for the separate groups: before hip replacement, within 2 hours after CABG and within 12 hours after admission for septic patients

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026