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Risk Factors for Early POCD in the Patients With PSM Undergoing CRS-HIPEC

Sponsor
Wuhan University (Other)
Overall Status
Completed
CT.gov ID
NCT02462564
Collaborator
(none)
31
Enrollment
1
Location
12
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Objectives to investigate the incidence and associated factors for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy(CRS-HIPEC).Methods fifty patients aged 18-65 yr were included in the research and were grouped base on the score of neuropsychological assessments which had done in the ward at 7 day before and after the surgery. The investigators monitored various indicators in the perioperative period, such as age, body weight, sex, education, duration of operation, intraoperative blood loss, cardiovascular events, amount of fluid infused per hour. Meanwhile, the concentration of serum amploid A (SAA),IL-1beta,TNF-alpha,HMGB1,S100b,cortisol and Abeta40 were measured at the various stage of the operation and 24 hours after the operation, and the differences of data between postoperative cognitive dysfunction(POCD) and Non-POCD groups were analyzed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    31 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Risk Factors for Early POCD(Postoperative Cognitive Dysfunction) in the Patients With PSM(Peritoneal Surface Malignancies )Undergoing CRS(Cytoreductive Surgery) and HIPEC(Hyperthermic Intraperitoneal Chemo-therapy)
    Study Start Date :
    Jun 1, 2014
    Actual Primary Completion Date :
    Jan 1, 2015
    Actual Study Completion Date :
    Jun 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    postoperative cognitive dysfunction

    Z score>1.96
    non-postoperative cognitive dysfunction

    Z score<1.96

    Outcome Measures

    Primary Outcome Measures

    1. Incidence for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy [12 months]

    Secondary Outcome Measures

    1. Risk factor for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • age < 65 years or >18 years

    • The patients with peritoneal surface malignancies willing to undergo the cytoreductive surgery with hyperthermic intraperitoneal chemotherapy

    Exclusion Criteria:

    • age < 18 years or >65 years

    • several organ function severely abnormal and can not tolerate the surgery,such as suffering from severely anemia, liver and renal function disfunction, heart and cerebrovascular disease

    • cognitive function was assessed by Mini-Mental State Examination (MMSE) at 1 day before operation and the score<23

    • people with neurological and psychiatric disease, such as anxiety, senile dementia, stroke sequela, cerebral hemorrhage, etc

    • psychiatric drug abusers

    • patients reluctant to go along with the trial

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zhongnan Hospital in Wuhan University Wuhan Hubei China 430074

    Sponsors and Collaborators

    • Wuhan University

    Investigators

    • Principal Investigator: Mian Peng, Doctor, Zhongnan Hospital in Wuhan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mian Peng, Doctor, Wuhan University
    ClinicalTrials.gov Identifier:
    NCT02462564
    Other Study ID Numbers:
    • HYu
    First Posted:
    Jun 4, 2015
    Last Update Posted:
    Aug 18, 2015
    Last Verified:
    Aug 1, 2015
    Keywords provided by Mian Peng, Doctor, Wuhan University
    peritoneal surface malignancies
    Post operative cognitive dysfunction
    Additional relevant MeSH terms:
    Peritoneal Neoplasms
    Postoperative Cognitive Complications
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Aug 18, 2015