Plasma Volume Replacement (PVR) Therapy With Colloid and Crystalloid Solutions

B. Braun

Status and phase: Completed; Phase 4

Conditions: Plasma Volume Replacement; Surgery of the Pancreatic Head

Treatments: Drug: balanced electrolyte solution; Drug: HES 6%; Drug: HES 10%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01117649

HC-G-H-0803

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy of target controlled fluid therapy with a hyper-oncotic balanced HES solution compared to an iso-oncotic HES solution in patients undergoing elective surgery of the pancreatic head. A third group receiving a balanced electrolyte solution (without colloidal volume replacement) will serve as a control for descriptive analysis.

Enrollment: 63 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

• patients scheduled to undergo elective surgery of the pancreatic head
• patients who are willing to give of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the Institutional Ethics Committee (IEC) prior to all evaluations.

Exclusion:

• patients of American Society of Anesthesiologists (ASA) class > III
• heart failure defined as New York Heart Association (NYHA) class>2
• aneurysm of the ascending and thoracic aorta
• patients with Zenker's diverticle
• local oesophageal disease (oesophageal stricture, oesophageal varices, previous oesophageal surgery in past 6 months before study inclusion, pharyngeal pouch)
• patients receiving haemodialysis
• patients with known bleeding diatheses
• any bleeding disorder known from patient's history
• patients with a haematocrit <= 25% despite pre-operative transfusion
• renal insufficiency (serum creatinine > 130 µmol/l or >1.5 mg/dl) or oliguria or anuria
• impaired hepatic function defined as Mayo End-Stage Liver Disease (MELD) > 10 or liver cirrhosis Child-Pugh B or C
• additional contra-indications for investigational products

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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63 participants in 3 patient groups

1

Experimental group

Description:

hyper-oncotic colloid

Treatment:

Drug: HES 10%

2

Active Comparator group

Description:

iso-oncotic colloid

Treatment:

Drug: HES 6%

3

Active Comparator group

Description:

crystalloid

Treatment:

Drug: balanced electrolyte solution