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

NCT ID: NCT01117649

Last Updated: 2016-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-07-31

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.

Detailed Description

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Conditions

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Plasma Volume Replacement Surgery of the Pancreatic Head

Keywords

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PVR HES 130 pancreatic head goal-directed intraoperative PVR in elective surgery of the pancreatic head

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

hyper-oncotic colloid

Group Type EXPERIMENTAL

HES 10%

Intervention Type DRUG

HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).

2

iso-oncotic colloid

Group Type ACTIVE_COMPARATOR

HES 6%

Intervention Type DRUG

HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)

3

crystalloid

Group Type ACTIVE_COMPARATOR

balanced electrolyte solution

Intervention Type DRUG

plasma adapted Ringer's solution

Interventions

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HES 10%

HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).

Intervention Type DRUG

HES 6%

HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)

Intervention Type DRUG

balanced electrolyte solution

plasma adapted Ringer's solution

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Melsungen AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia Spies, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum

Locations

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Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin

Berlin, , Germany

Site Status

Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum

Berlin, , Germany

Site Status

Universitätsklinikum Bonn

Bonn, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HC-G-H-0803

Identifier Type: -

Identifier Source: org_study_id