s100β, NSE n GFAP in Living Donor Hepatectomy and Delirium

NCT04422925 | Completed

• 1 other identifier: s100β, NSE n GFAP in LDH
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The post-operative delirium picture is a serious and common complication seen after any major surgery, including hepatic resection. Patients who will be planned to undergo donor hepatectomy for liver transplantation will be included in the study. Basic clinical and demographic information of patients undergoes donor hepatectomy will be recorded before surgery. The anatomical parameters such as liver volume, medications performed during the surgery, complications, bleeding amounts, fluids given, blood and blood products, vital signs during surgery, fluid balance, duration of surgery, recovery length at post-operative period, complications after surgery, approaches to complications, analgesics and other medications used, hemogram and other biochemical parameters (electrolytes, albumin, liver frontier tests, etc.), weight status, vital signs, duration of intensive care, post-operative VAS scores, drainage and information such as length of stay, length of hospital stay, the healing time of the wound will also be recorded. During the hospitalization, the delirium status of the patients will be evaluated with a delirium evaluation scale by consultant doctor. Blood will be taken for the measurement of S100β, NSE, and GFAP levels one day before donor hepatectomy and following day of hepatectomy, 3rd day, and 7th day in the post-operative period. The plasma of the blood taken will be separated and stored at -80 0C until working. Laboratory values are taken from the patients before the operation will be recorded over the system. The relationship between the results obtained and the delirium evaluation scores performed on the days followed will be evaluated. This study aims to analyze the delirium incidence and post-operative early S100β, NSE, and GFAP levels within the first week following the hepatectomy performed in live donors for liver transplantation.

Conditions

Donor Site Complication; Delirium; Uremic Encephalopathy; Neurologic Manifestations

Keywords

donor living hepatectomy; s100β; neuron specific enolase; glial fibrillary acidic protein; delirium

Outcome Measures

Primary Outcomes (4)

• Assessment of serum s100β

  Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze S100β serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.

  2 years

• Assessment of serum NSE

  Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze NSE serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.

  2 years

• Assessment of serum GFAP

  Approximately 25 patients planned to have living donor hepatectomy will be included in the study. The blood samples are taken in the preoperative period before the induction of anesthesia in the operating room and postoperative (the first day, the third day and the seventh day) period to analyze GFAP serum concentrations and neurologic damage of living donor hepatectomy patients besides evaluating its effect on prognosis. These samples shall be kept at -80 0C until the plasma separation process.

  2 years

• Assessment of serum cognitive functions and delirium status

  During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point.

  2 years

Interventions

Living Donor Hepatectomy PROCEDURE

On living donor hepatectomy (preoperative), the first following day of surgery, 3rd day, and 7th day, blood will be taken for the measurement of S100β, NSE, and GFAP levels in the postoperative period. The plasma of the blood taken will be separated and stored at -800C. Values will be measured by the ELISA method. During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point.

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients' demographic data (age, gender, weight, height), accompanying diseases, ASA classification, main etiology, preoperative serums taken in the preoperative period; serum sodium, potassium, ammonium, total bilirubin, ALT, AST, albumin, alkaline phosphatase, INR, creatinine, and BUN shall be recorded accordingly. In addition, routinely taken anesthetics, duration of the operation, duration of anesthesia, duration before the reperfusion, duration of postperfusion, first measured central venous pressure, volume replacement therapy, blood component transfusion, the total fluid amount given during the operation, corticosteroids and immunosuppressive drugs given during the operation shall be recorded. Besides, the cognitive functions of the patients and blood samples for mentioned values will be evaluated in the preoperative and postoperative periods.

You may qualify if:

• Patients who are admitted as a donor who will undergo living donor hepatectomy operation by Akdeniz University Faculty of Medicine Organ Transplant Center and planned to have a donor right hepatectomy operation
• Patients who have read and accepted the detailed informed consent form

You may not qualify if:

• Failure to supply routine blood sampling during follow-up
• Having major complications after surgery (pulmonary embolization, sepsis, etc.)
• Individuals with mental health disorders detected by the organ transplantation committee in the preoperative period.

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Medical Faculty Department of Anesthesiology and Reanimation

Antalya, 07059, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

s100β, neuron specific enolase and glial fibrillary acidic

MeSH Terms

Conditions

Delirium; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Bora Di̇nc, MD, Assist. Prof.

  Akdeniz University Medical Faculty

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Assist. Prof.

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: September 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Locations

TU (1)