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Completed

NCT Number: NCT02912299

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

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

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Key information

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Skin biopsies

Procedure

2 3mm skin biopsies will be taken

Blood and urine analysis

Other

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

Blood collection for RNA-investigation

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

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

Acronym: InCa

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Sep 23, 2016
Registry last updated
Sep 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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