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

SUbstition of PERioperative Albumin Deficiency Disorders - SUPERADD

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-001313-24-DE

Enrollment

600

Registered

2016-09-05

Start date

2017-02-13

Completion date

Unknown

Last updated

2021-04-05

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

Conditions

High risk surgical patients or procedures showing a hypoalbuminemia intraoperatively. MedDRA version: 20.0 Level: PT Classification code 10005286 Term: Blood albumin abnormal System Organ Class: 10022891 - Investigations MedDRA version: 20.0 Level: PT Classification code 10005287 Term: Blood albumin decreased System Organ Class: 10022891 - Investigations MedDRA version: 20.1 Level: LLT Classification code 10020943 Term: Hypoalbuminemia System Organ Class: 10027433 - Metabolism and nutrition d

Interventions

Trade Name: Human-Albumin 20 % Behring, salzarm Infusionslösung Product Name: Human-Albumin 20 % Behring, salzarm Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Outcomes are: 1. PACU length of stay 2. ICU length of stay 3. hospital length of stay 4. clavien dindo over the hospital stay 5. hospital mortality 6. Quality of recovery -9 (QoR-9) score on 1. and 3. postoperative day and 6 months after hospital discharge, including changes to base value (assessed during presurgical anesthesia assessment) 7. incidence of 6 month mortality 8. incidence of acute renal failure (acute kidney injury (AKI) = 1) 9. incidence of pulmonalvenous congestions (assessed by chest Xray) 10. intra- and postoperative catecholamine requirements 11. incidence and duration of intra- and postoperative hypotension (defined as values < 30% of basic value before anesthesia induction as well as vasopressor therapy) 12. amount of infusions (anesthesia induction till PACU-discharge) 13. amount of transfused red blood cell units (anesthesia induction till PACU-discharge) 14. amount of transfused thrombocytes (anesthesia induction till PACU-discharge) 15. amount of transfused clotting factors (PCC and fibrinogen, assessed from anesthesia induction till PACU discharge) 16. new, intermittent or escalated diuretic therapy 17. effectivitiy of albumin therapy to raise the albumin level and colloidosmotic pressure;Timepoint(s) of evaluation of this end point: Most secondary endpoints are assessed at hospital discharge. In addition, 6-months mortality and the QoR-9 are assessed 6 months after hospital discharge. Vasopressor requirements, hypotension, infusions, red blood cell units, thrombocyte transfusions and clotting factors are assessed from anesthesia induction till PACU discharge.	—

Measure

Time frame

Secondary end point(s): Secondary Outcomes are: 1. PACU length of stay 2. ICU length of stay 3. hospital length of stay 4. clavien dindo over the hospital stay 5. hospital mortality 6. Quality of recovery -9 (QoR-9) score on 1. and 3. postoperative day and 6 months after hospital discharge, including changes to base value (assessed during presurgical anesthesia assessment) 7. incidence of 6 month mortality 8. incidence of acute renal failure (acute kidney injury (AKI) = 1) 9. incidence of pulmonalvenous congestions (assessed by chest Xray) 10. intra- and postoperative catecholamine requirements 11. incidence and duration of intra- and postoperative hypotension (defined as values < 30% of basic value before anesthesia induction as well as vasopressor therapy) 12. amount of infusions (anesthesia induction till PACU-discharge) 13. amount of transfused red blood cell units (anesthesia induction till PACU-discharge) 14. amount of transfused thrombocytes (anesthesia induction till PACU-discharge) 15. amount of transfused clotting factors (PCC and fibrinogen, assessed from anesthesia induction till PACU discharge) 16. new, intermittent or escalated diuretic therapy 17. effectivitiy of albumin therapy to raise the albumin level and colloidosmotic pressure;Timepoint(s) of evaluation of this end point: Most secondary endpoints are assessed at hospital discharge. In addition, 6-months mortality and the QoR-9 are assessed 6 months after hospital discharge. Vasopressor requirements, hypotension, infusions, red blood cell units, thrombocyte transfusions and clotting factors are assessed from anesthesia induction till PACU discharge.

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Countries

Germany

Contacts

Public ContactKlinik für Anästhesiologie

Technische Universität München, Fakultät für Medizin

s.schaller@tum.de498941409635

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 26, 2026