Overview

SUbstition of PERioperative Albumin Deficiency Disorders

Status:
Completed
Trial end date:
2021-04-21
Target enrollment:
0
Participant gender:
All
Summary
Aim of this study is to reduce postoperative complications (assessed by POMS-Score and graded by Clavien-Dindo-Score) by substitution of perioperative hypoalbuminaemia in high-risk patients or patients undergoing high risk surgery.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Technische Universität München
Criteria
Inclusion Criteria:

- age: 18 years or older

- written informed consent

- ASA state 3 and 4 OR

- elective high risk surgery (open aortic surgery, open leg revascularization,
thrombectomy, oesophagectomy, pancreatic surgery, cystectomy, liver surgery, change of
knee- or hip-prothesis, amputation)

Exclusion Criteria:

- emergency surgery

- severe liver cirrhosis (child pugh C)

- need for dialysis

- patients already included in SUPERADD

- patients with a legal representative

- contraindications for human albumin: hypersensitivity for human albumin or any
substance included in the preparation

- pregnancy

- breastfeeding women

- ASA state 5

- BMI > 35 kg/m2