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Completed

NCT Number: NCT01117649

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

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.

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Key information

Conditions

Plasma Volume Replacement Surgery of the Pancreatic Head

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HES 10%

Drug

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

HES 6%

Drug

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

balanced electrolyte solution

Drug

plasma adapted Ringer's solution

Primary outcomes

  1. First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)

    Time frame: up to 8 hours

    Goal-directed (stroke volume) plasma volume therapy

  2. Second endpoint: Time until fully on oral (solid) diet (days)

    Time frame: up to 15 days

Secondary outcomes

  1. haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores

    Time frame: up to 7 days

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
May 5, 2010
Registry last updated
Dec 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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