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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-03

Study Completion Date

2017-09-05

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hypernatremia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Skin biopsies

Intervention Type PROCEDURE

2 3mm skin biopsies will be taken

Blood and urine analysis

Intervention Type OTHER

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

Blood collection for RNA-investigation

Intervention Type OTHER

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

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.

Skin biopsies

Intervention Type PROCEDURE

2 3mm skin biopsies will be taken

Blood and urine analysis

Intervention Type OTHER

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

Blood collection for RNA-investigation

Intervention Type OTHER

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

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.

Skin biopsies

Intervention Type PROCEDURE

2 3mm skin biopsies will be taken

Blood and urine analysis

Intervention Type OTHER

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

Blood collection for RNA-investigation

Intervention Type OTHER

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

Interventions

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Skin biopsies

2 3mm skin biopsies will be taken

Intervention Type PROCEDURE

Blood and urine analysis

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

Intervention Type OTHER

Blood collection for RNA-investigation

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No