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Effect of early perioperative target directed infusion of human blood albumin on postoperative complications in patients with oral cancer undergoing free flap transplantation

Effect of early perioperative target directed infusion of human blood albumin on postoperative complications in patients with oral cancer undergoing free flap transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094058
Enrollment
Unknown
Registered
2024-12-16
Start date
2025-01-01
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

patients undergoing oral cancer microvascular free flap surgery

Interventions

Experimental group (early albumin intervention group):Serum albumin was measured every 4 hours from induction of anesthesia until 24 hours after surgery. If the serum albumin concentration decreased b
Control group (conventional treatment group):When plasma albumin levels are not measured during the operation or within 24 hours after surgery, human albumin infusion is not given (unless hemodynamica

Sponsors

Third Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) 18-80 years old; 2) Tumor resection and free flap reconstruction for oral and maxillofacial malignancies; 3) Nutritional risk screening (NRS-2002) score =3 points; 4) Preoperative albumin 24h; 6) Obtain informed consent from the patient or family.

Exclusion criteria

Exclusion criteria: 1) Known or suspected allergy to albumin; 2) Pregnant and lactating women; 3) Severe obesity (BMI = 35 kg/m2); 4) Have suffered from severe cardiovascular, respiratory, liver, kidney, blood and immune diseases, which can be defined as: NYHA classification of cardiac function > Class ?; Active myocardial ischemia; Cardiovascular interventions in the past 60 days; Liver cirrhosis; Chronic kidney disease with creatinine clearance < 40ml/min or chronic obstructive disease requiring home oxygen therapy; 5) Patients who have stopped treatment due to poor prognosis; 6) Patients enrolled in other studies within 3 months.

Design outcomes

Primary

MeasureTime frame
The incidence of postoperative complications in patients with at least one clinically relevant Clavien-Dindo classification (CDC) =2 within the first 30 days after surgery;Intraoperative and 24h postoperative fluid volume;Total amount of vasoactive drugs during and after operation;

Secondary

MeasureTime frame
Quality of postoperative recovery (QoR15);Flap complication;Wound complication;pulmonary complications;cardiovascular complication;Non-scheduled second surgery after surgery;postoperative delirium;Postoperative hospital stay;Stay at home for 30 days after surgery (DAH30);Re-admission within 30 days after surgery;Death within 30 days;

Countries

China

Contacts

Public ContactHaopeng Zhang

The Third Hospital of the Air Force Medical University

haopeng.zhang@foxmail.com+86 135 7219 0222

Outcome results

None listed

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