Can the compensation of protein deficits, which occur during or after surgery, improve outcome after surgery?

Phase 1

• Conditions: High risk surgical patients or procedures showing a hypoalbuminemia intraoperatively.; MedDRA version: 20.0Level: PTClassification code 10005286Term: Blood albumin abnormalSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.0Level: PTClassification code 10005287Term: Blood albumin decreasedSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: LLTClassification code 10020943Term: HypoalbuminemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 20.0Level: PTClassification code 10020942Term: HypoalbuminaemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-001313-24-DE
• Lead Sponsor: Technische Universität München, Fakultät für Medizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-05
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. patients older than 18 years
2. patients, who voluntarily signed the consent form of the study
3. a. ASA III or IV
OR
b. planned high risk surgery: open aortic surgery, open revascularization of lower limbs, esophagectomy, cystectomy, pancreatic surgery, hepatic surgery, thrombectomy/embolectomy, amputation of a limb, replacement of artificial hip or knee joint
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 390

Exclusion Criteria

1. emergency surgery
2. severe liver cirrhosis (Child Pugh C)
3. terminal renal insufficiency needing renal replacement therapy
4. patients, who have been randomized in SUPERADD before
5. patients having a caregiver in medical affairs
6. patients with contraindications for albumin
7. patients allergic to albumin or substances in the albumin preparation
8. pregnant women
9. breastfeeding women
10. patient with a BMI > 35 kg/m2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Reduction of postoperative complications of either high-risk surgical procedures or high-risk surgical patients through perioperative therapy of hypoalbuminemia (defined as <30g/l). ;Secondary Objective: Amelioration of the below defined secondary outcomes of either high-risk surgical procedures or high-risk surgical patients through perioperative therapy of hypoalbuminemia (defined as <30g/l).;Primary end point(s): Postoperative Complications assessed by POMS (Postoperative Morbidity Survey) and Clavien-Dindo-Score.;Timepoint(s) of evaluation of this end point: At hospital discharge