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

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Controlled, Double-blind, Randomized Multi-centric Study on the Efficacy and Safety of a Target Controlled PVR Therapy With a Hyperoncotic Balanced Hydroxyethyl Starch (HES) Solution Versus an Isooncotic Balanced HES Solution Compared to a Balanced Electrolyte Solution in Elective Surgery

Conditions
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Plasma Volume Replacement, Surgery of the Pancreatic Head

Intervention / Treatment
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* Drug: HES 10%
* Drug: HES 6%
* Drug: balanced electrolyte solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>hyper-oncotic colloid | Drug: HES 10%<br>* HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).<br>|
| Active Comparator: 2<br>iso-oncotic colloid | Drug: HES 6%<br>* HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)<br>|
| Active Comparator: 3<br>crystalloid | Drug: balanced electrolyte solution<br>* plasma adapted Ringer's solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml) | Goal-directed (stroke volume) plasma volume therapy | up to 8 hours | 
| Second endpoint: Time until fully on oral (solid) diet (days) |  | up to 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores |  | up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PVR, HES 130, pancreatic head, goal-directed, intraoperative PVR in elective surgery of the pancreatic head