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

M

Medical Centre Leeuwarden

Status

Completed

Conditions

Hypernatremia

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT02912299
NL 56729.099.16

Details and patient eligibility

About

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

Full 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.

Enrollment

45 patients

Sex

All

Ages

45 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

45 participants in 3 patient groups

Septic patients
Description:
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.
Treatment:
Other: Blood collection for RNA-investigation
Other: Blood and urine analysis
Procedure: Skin biopsies
CABG patients
Description:
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.
Treatment:
Other: Blood collection for RNA-investigation
Other: Blood and urine analysis
Procedure: Skin biopsies
Patients before hip replacement
Description:
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.
Treatment:
Other: Blood collection for RNA-investigation
Other: Blood and urine analysis
Procedure: Skin biopsies

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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