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

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ClinicalTrials.gov Identifier: NCT02912299
Recruitment Status : Completed
First Posted : September 23, 2016
Last Update Posted : September 8, 2017
Sponsor:
Collaborator:
University Medical Center Groningen
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hypernatremia Procedure: Skin biopsies Other: Blood and urine analysis Other: Blood collection for RNA-investigation

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.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Onderzoek Naar Intracutane Natriumopslag Bij Intensive Care patiënten (InCa-studie)
Actual Study Start Date : November 3, 2016
Actual Primary Completion Date : September 5, 2017
Actual Study Completion Date : September 5, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Group/Cohort Intervention/treatment
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.
Procedure: Skin biopsies
2 3mm skin biopsies will be taken

Other: Blood and urine analysis
Measurement of sodium, potassium and kidneyfunction in blood and urine.

Other: Blood collection for RNA-investigation
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.
Procedure: Skin biopsies
2 3mm skin biopsies will be taken

Other: Blood and urine analysis
Measurement of sodium, potassium and kidneyfunction in blood and urine.

Other: Blood collection for RNA-investigation
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.
Procedure: Skin biopsies
2 3mm skin biopsies will be taken

Other: Blood and urine analysis
Measurement of sodium, potassium and kidneyfunction in blood and urine.

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Slides for microscopic investigations, containing slices of the skin biopsies. These biopsies are only diagnostic and these are specific and only for study properties. Study involvement will not influence diagnostic or therapeutic interventions that are due to common treatment.


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Ages Eligible for Study:   45 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • 15 patients admitted to the ICU with systemic inflammatory response syndrom in the presence of a(n expected) new infection
  • 15 patients admitted to the ICU after coronary artery bypass surgery, matched by gender and age (+/- 10 years) to the septic patients
  • 15 patients undergoing a hip replacement for arthrosis, matched by gender and age (+/- 10 years) to the septic patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02912299


Locations
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Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Netherlands
Sponsors and Collaborators
Medical Centre Leeuwarden
University Medical Center Groningen
Investigators
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Principal Investigator: Christiaan Boerma, MD PhD Medical Center Leeuwarden
Principal Investigator: Jaap van den Born, PhD University Medical Center Groningen
Publications:
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Responsible Party: Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT02912299    
Other Study ID Numbers: NL 56729.099.16
First Posted: September 23, 2016    Key Record Dates
Last Update Posted: September 8, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Depending on the requests of the magazine involved.
Additional relevant MeSH terms:
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Hypernatremia
Water-Electrolyte Imbalance
Metabolic Diseases