NCT03167645

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

2.5 years

First QC Date

October 18, 2016

Last Update Submit

April 22, 2021

Conditions

Hypoalbuminemia

Outcome Measures

Primary Outcomes (1)

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

    Postoperative complications will be detected using the POMS score. The severity of the complications will be graded with the Clavien-Dindo-Score. A complication will be regarded as clinical relevant when it is graded Clavien-Dindo-Score 2 or higher on at least one of the four days examined.

    15 days

Secondary Outcomes (16)

  • Length of hospital stay

    until discharge from hospital, up to 6 month

  • Length of stay in postoperative anaesthesia care unit

    until discharge from postoperative anaesthesia care unit, up to 24 hours

  • Length of stay in intensive care unit

    until discharge from intensive care unit, up to 1 month

  • Long term mortality (6 month)

    6 month

  • Short term mortality (hospital mortality)

    until discharge from hospital, up to 6 month

  • +11 more secondary outcomes

Study Arms (2)

Human albumin

EXPERIMENTAL

Substitution of human albumin until serum albumin \>30g/l; dosage: (30 g/l - serum albumin \[g/l\] ) x 0,04 l/kg x body weight \[kg\] x 2

Drug: Human albumin

Control

NO INTERVENTION

Standard clinical care

Interventions

Human albuminDRUG

Substitution according to pre-specified dosage

Also known as: Human-Albumin 20 % Behring, salzarm
Human albumin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar Dept. of Anesthesiology

Munich, 81675, Germany

Location

Related Publications (3)

  • Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26.

    PMID: 1598671BACKGROUND

  • Grocott MP, Browne JP, Van der Meulen J, Matejowsky C, Mutch M, Hamilton MA, Levett DZ, Emberton M, Haddad FS, Mythen MG. The Postoperative Morbidity Survey was validated and used to describe morbidity after major surgery. J Clin Epidemiol. 2007 Sep;60(9):919-28. doi: 10.1016/j.jclinepi.2006.12.003. Epub 2007 May 7.

    PMID: 17689808BACKGROUND

  • Schaller SJ, Fuest K, Ulm B, Schmid S, Bubb C, von Eisenhart-Rothe R, Friess H, Kirchhoff C, Stadlbauer T, Luppa P, Blobner M, Jungwirth B. Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial. Trials. 2020 Aug 18;21(1):726. doi: 10.1186/s13063-020-04626-2.

    PMID: 32811539DERIVED

MeSH Terms

Conditions

Hypoalbuminemia

Interventions

Serum Albumin, HumanAlbumins

Condition Hierarchy (Ancestors)

HypoproteinemiaBlood Protein DisordersHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Serum AlbuminProteinsAmino Acids, Peptides, and ProteinsBlood Proteins

Study Officials

  • Manfred Blobner, MD

    Klinikum rechts der Isar, Technical University Munich, Dept. of Anesthesiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2016

First Posted

May 30, 2017

Study Start

June 19, 2017

Primary Completion

December 21, 2019

Study Completion

April 21, 2021

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)