Association of Haptoglobin 2-2 With Postoperative Delirium

Determination of the Association of Haptoglobin 2-2 With Delirium After Orthopedic Surgery

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03392480

Enrollment

Registered

2018-01-08

Start date

2017-12-20

Completion date

2019-12-30

Last updated

2023-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Delirium

Brief summary

Patients with major orthopedic surgery will be recruited. Participants will be monitored for delirium after surgery. Participants' blood will be harvested for the determination of haptoglobin types, levels of oxidative stress and inflammation. Investigators will then analyze the data to see if haptoglobin 2-2 type is associated with an increased postoperative delirium, inflammation and oxidative stress.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Inclusion criteria

* American Society of Anesthesiologists physical status I to III class for major orthopedic surgery (hip or knee replacement or spinal surgery) * No psychological and psychiatric history and presentation before surgery * No major organ dysfunction or failure

Exclusion criteria

* Anemia (hemoglobin \< 100 g/l) preoperatively. * Requires \> 4 units of allogeneic red blood cell transfusion during the surgery * Using steroids or anti-psychological and anti-psychiatric drugs. A small dose of steroid for postoperative anti-nausea/vomiting is allowed and will not be considered as a indication for exclusion. * Can not cooperate with the study * History of bleeding * BMI \< 18 or \> 30 * History of hemoglobin metabolism disorder

Design outcomes

Primary

Measure	Time frame	Description
Postoperative delirium incidence	From day 0 to up to 7 days after the surgery	The incidence of delirium as assessed by intensive care unit-confusion assessment method will be determined.
Postoperative delirium duration	From day 0 to up to 7 days after the surgery	The duration of delirium as assessed by intensive care unit-confusion assessment method will be determined.

Secondary

Measure	Time frame	Description
Oxidative stress level	Day 0 to day 2 after the surgery	The level of malondialdehyde in the blood will be measured by ELISA.
Inflammation level	Day 0 to day 2 after the surgery	The levels of interleukin 1beta and interleukin 6 in the blood will be assessed by ELISA.

Countries

China

Outcome results