Comparison Between Hyperoncotic and Isooncotic Albumin to Support Blood Loss Replacement

NCT ID: NCT05391607

Last Updated: 2023-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-25
• Study Completion Date: 2023-04-10

Brief Summary

Fluid intravascular replacement is usually performed with either balanced crystalloids or iso-oncotic colloids, (synthetic colloids, plasma and 5% albumin). Doubts have been raised about synthetic colloids, and albumin solutions have been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect. The mobilization of extravascular fluid by infusing a hyper-oncotic solution like 20% albumin solution has been shown, causing endogenous fluid recruitment and blood volume expansion.

The primary objective of this study is to compare the effect on plasma volume expansion and fluid recruitment of 3 different types of fluids (Albumin 5% and Albumin 20% and Ringer-lactate) during the hemorrhagic phase of the cystectomy procedure.

Secondary objectives are the assessment of the hemodynamic parameters during surgery and the follow-up of pro-ANP and pro-BNP peptides. Glycocalyx proteins will be followed to evaluate endothelial wall shedding and microcirculation damages.

Detailed Description

Bladder cancer occurs mainly in old comorbid patients. The standard treatment of localized muscle invasive bladder cancer is pelvic lymph node dissection and radical cystectomy with urinary diversion. Optimal perioperative fluid management for this surgery is challenging and still controversial in terms of how much to perfuse, choice of fluids to restore hydrated state and volemia.

Fluid treatment is usually performed with either balanced crystalloids fluids or iso-oncotic synthetic colloids, or albumin 5%. Because crystalloids quickly equilibrate between the intravascular and interstitial volumes, they are mainly used to treat dehydration and temporary volume deficits. Doubts have been raised about synthetic colloids and the natural albumin has been used more extensively. Albumin is the main protein responsible for plasma oncotic pressure and its volume expansion effect.

Iso-oncotic colloids (Albumine 5%) remain intravascular for a prolonged period, but they play a neutral role in terms of endogenous fluid recruitment, as the oncotic pressure is equilibrated between the intra- and extra- vascular territories.

An alternative therapeutic option is the mobilization of tissue fluid by infusing a small amount of hyper-oncotic fluid like the albumin 20% solution, which has showed the advantage in its blood volume expansion capacities over crystalloids (endogenous fluid recruitment).

The effects of the Albumin 20% solution have until now never been compared in a same perioperative setting to the Albumin 5% nor to Ringer-lactate solution.

The investigators will evaluate the physiological effects and their outcomes between these fluid therapies in the frame of blood loss replacement during the hemorrhagic part of cystectomy procedures. The investigators will as well assess the variation of hemodynamic parameters (pro-ANP, pro-BNP) and the resulting microcirculation damages (endothelial wall shedding).

Conditions

Blood Loss, Surgical; Fluid Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Albumin 20%

3mL/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Group Type: EXPERIMENTAL

Hyperoncotic Albumin 20%

Intervention Type: DRUG

Intravenous administration during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Albumin 5%

12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Group Type: EXPERIMENTAL

Isooncotic Albumin 5%

Intervention Type: DRUG

Intravenous administration of Albumin 5% 12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Ringer-lactate

Ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Group Type: ACTIVE_COMPARATOR

Ringer's Lactate Crystalloid Solutions (control group)

Intervention Type: DRUG

Intravenous administration of Ringer-lactate ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Interventions

Hyperoncotic Albumin 20%

Intravenous administration during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Intervention Type: DRUG

Isooncotic Albumin 5%

Intravenous administration of Albumin 5% 12ml/kg (ideal body weight) completed by a Ringer-lactate crystalloid ratio 1:1 to total amount of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Intervention Type: DRUG

Ringer's Lactate Crystalloid Solutions (control group)

Intravenous administration of Ringer-lactate ratio 3:1 of total of blood loss during removal of the bladder (i.e. the bleeding part) of cystectomy procedures.

Intervention Type: DRUG

Other Intervention Names

Albumin 20%; Albumin 5%; Ringer Lactate

Eligibility Criteria

Inclusion Criteria

• Non emergent radical cystectomy with urinary diversion
• Adult: older than 18 years
• Written informed consent

Exclusion Criteria

• Contraindications to the class of drugs under study (i.e: known hypersensitivity/ allergy to class of drugs or to the investigational product).
• Renal insufficiency: GFR: <60ml/min/1.73m2 (KDIGO Clinical Practice Guideline for Acute Kidney Injury, stage 3 and over).
• History of heart failure.
• Use of diuretic treatment.
• Women who are pregnant or breast feeding (exclusion of surgery per se).
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
• Enrolment of the investigator, his/her family members, employees and other dependent persons.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Y Wuethrich, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Patrick Wuethrich, Department of Anaesthesiology and Pain Therapy, University Hospital Bern Inselspital Bern

Bern, Canton of Bern, Switzerland

Countries

Switzerland

References

Jardot F, Hahn RG, Huber M, Wuethrich PY. Detection of hypovolemia by non-invasive hemodynamic monitoring during major surgery using Ringer s solution, 5% albumin, or 20% albumin as infusion fluid: a post-hoc analysis of a randomized clinical trial. Crit Care. 2025 Mar 23;29(1):132. doi: 10.1186/s13054-025-05357-z.

Reference Type: DERIVED

PMID: 40122881 (View on PubMed)

Jardot F, Hahn RG, Engel D, Beilstein CM, Wuethrich PY. Blood volume and hemodynamics during treatment of major hemorrhage with Ringer solution, 5% albumin, and 20% albumin: a single-center randomized controlled trial. Crit Care. 2024 Feb 5;28(1):39. doi: 10.1186/s13054-024-04821-6.

Reference Type: DERIVED

PMID: 38317178 (View on PubMed)

Other Identifiers

VASCALB

Identifier Type: -

Identifier Source: org_study_id