Clinical trial NCT02462564: Risk Factors for Early POCD in the Patients With PSM Undergoing CRS-HIPEC
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Cognitive Dysfunction
Keywords: peritoneal surface malignancies
Post operative cognitive dysfunction
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy
timeFrame: 12 months
Secondary outcomes:
measure: Risk factor for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy
timeFrame: 12 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital in Wuhan University
state: Hubei
Study officials:
affiliation: Zhongnan Hospital in Wuhan University
name: Mian Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References: