NCT03058328

Brief Summary

The purpose of this study is to describe numerical and functional changes in the white blood cell efter surgical trauma. Further, observed immune cell changes correlate to heart rate variability and cognitive function will be assessed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

January 31, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

5.9 years

First QC Date

January 13, 2017

Last Update Submit

January 15, 2024

Conditions

Neuroinflammation

Keywords

Inflammation/physiopathology, Immune System/immunology,Neuroimmunomodulation/physiology, General SurgeryHeart Rate/physiology*Vagus Nerve/physiology*

Outcome Measures

Primary Outcomes (1)

  • Changes in subsets of Monocytes after surgical trauma

    Changes in subsets of Monocytes after surgical trauma

    Up to 6 months after surgery

Secondary Outcomes (4)

  • T-cell numbers after surgical trauma.

    Up to 6 months after surgery

  • B-cell numbers after surgical trauma.

    Up to 6 months after surgery

  • T-cell functionality changes after surgical trauma.

    Up to 6 months after surgery

  • B-cell functionality changes after surgical trauma.

    Up to 6 months after surgery

Other Outcomes (1)

  • Genetic response to surgical trauma

    Up to 6 months after surgery

Interventions

Cognitive testing, testing of heart rate variability and blood samplesOTHER

No intervention. Registration of ECG, cognitive testing and blood sampling is performed in the perioperative period and during follow up.

Eligibility Criteria

Age40 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diagnosed prostate disease who are scheduled for elective robot assisted prostate surgery (RALP) and who are otherwise healthy, with a BMI below 33 and who score \>23 performance points on Mini-mental state examination (MMSE).

You may qualify if:

  • Diagnosed prostate disease who are scheduled for elective robot assisted prostate surgery (RALP) and who are otherwise healthy
  • A body mass index (BMI) below 33
  • Mini-mental state examination (MMSE) scoring \>23

You may not qualify if:

  • Neurodegenerative disease
  • Significant psychiatric illness
  • Previous stroke
  • Pacemaker, myocardial infarction or cardiac arrhythmias,
  • Known obstructive coronary artery disease, left ventricular hypertrophy or New York Heart Association (NYHA) class 2-4 heart failure
  • Chronic pain or inflammatory disease such as rheumatoid arthritis, inflammatory bowel disease, SLE, psoriasis
  • Steroidal therapy
  • Statin medication
  • Medication with ß-blockers, anti-cholinergic medication
  • Poorly controlled diabetes mellitus or any other condition known to cause autonomic dysfunction
  • Abuse of alcohol or drugs
  • Previous splenectomy
  • Presumed uncooperativeness or legal incapacity.
  • The patient should not have:
  • undergone surgery the last 6 months
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Universitetssjukhuset Solna

Stockholm, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whoole blood from which PBMCs (Peripheral Blood Monocytic Cells), plasma, serum will be stored.

MeSH Terms

Conditions

Neuroinflammatory DiseasesInflammation

Interventions

Neuropsychological TestsBlood Specimen Collection

Condition Hierarchy (Ancestors)

Nervous System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and ActivitiesSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Lars I Eriksson

    Karolinska University Hospital and Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Senior Consultant

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 20, 2017

Study Start

January 31, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Locations

SE(1)