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

Postoperative Cognitive Dysfunction Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462564
• Other study ID #: HYu
• Status: Completed
• Phase: N/A
• First received: January 30, 2015
• Last updated: August 16, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: August 2015
• Source: Wuhan University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cognition Disorders
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
China	Zhongnan Hospital in Wuhan University	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy		12 months	Yes
Secondary	Risk factor for early postoperative cognitive dysfunction in the patients with peritoneal surface malignancies undergoing cytoreductive surgery and hyperthermic intraperitoneal chemo-therapy		12 months	Yes