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

NCT ID: NCT02462564

Last Updated: 2015-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Cognitive Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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postoperative cognitive dysfunction

Z score\>1.96

No interventions assigned to this group

non-postoperative cognitive dysfunction

Z score\<1.96

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Mian Peng

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mian Peng, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhongnan Hospital in Wuhan University

Locations

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Zhongnan Hospital in Wuhan University

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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HYu

Identifier Type: -

Identifier Source: org_study_id

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