CompletedPhase 4

SUbstition of PERioperative Albumin Deficiency Disorders

Germany600 participantsStarted 2017-06-19

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Postoperative complications assessed with POMS- and graded with Clavien-Dindo-Score

Timeframe: 15 days

Trial details

NCT IDNCT03167645

SponsorTechnical University of Munich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-21

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