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A single center, prospective and non inferior study on the feasibility of hypothermia in organ protection of aortic arch surgery

A single center, prospective and non inferior study on the feasibility of hypothermia in organ protection of aortic arch surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033852
Enrollment
Unknown
Registered
2020-06-14
Start date
2020-07-01
Completion date
Unknown
Last updated
2020-06-15

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

Conditions

Aortic lesion

Interventions

Group 2:moderate hypothermia
Group 1:mild hypothermia

Sponsors

Department of Cardiovascular Surgery, General Hospital of Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 to 80 years; 2. Patients with Stanford type A aortic dissection or arch aneurysm; 3. Patients without aortic valve disease or pericardial tamponade; 4. Patients without nervous system diseases; 5. Patients without organ damage confirmed by abdominal CT or B-ultrasound; 6. Patients who had the first heart operation; 7. Patients without congenital heart history; 8. Those patients who have good compliance and can cooperate with the follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with two or more cardiac operations; 2. Patients with heart operation accompanied by other body parts operation; 3. Patients with liver and kidney function damage (the detection result is more than 3 times of the upper limit of normal value) and operation contraindications; 4. Patients with other diseases requiring radiotherapy, chemotherapy and long-term hormone treatment; 5. Patients who have participated in other clinical trials.

Design outcomes

Primary

MeasureTime frame
The incidence of liver, kidney and brain complications in patients during perioperative period;

Secondary

MeasureTime frame
Days of hospital stay following surgery;Days of ICU stay;PCT, IL-6, hsCRP;extracorporeal circulation duration;Aortic occlusion duration;Ventilator assist duration;Perioperative blood transfusion;

Countries

China

Contacts

Public ContactHui Jiang

Department of Cardiovascular Surgery, General Hospital of Northern Theater Command

Jiangh33471@126.com+86 15309886855

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026