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

NCT01117649 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2016-12-23

No results posted yet for this study

Summary

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.

Conditions

  • Plasma Volume Replacement
  • Surgery of the Pancreatic Head

Interventions

DRUG

HES 10%

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

DRUG

HES 6%

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

DRUG

balanced electrolyte solution

plasma adapted Ringer's solution

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Claudia Spies, Prof. Dr. · Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-07-31
Completion
2013-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01117649 on ClinicalTrials.gov