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

Plasma Volume Replacement Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01117649
• Other study ID #: HC-G-H-0803
• Status: Completed
• Phase: Phase 4
• First received: April 28, 2010
• Last updated: December 22, 2016
• Start date: May 2010
• Est. completion date: July 2013

Study information

• Verified date: December 2016
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Plasma Volume Replacement
• Surgery of the Pancreatic Head

Intervention

Drug:
• HES 10%
HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).
• HES 6%
HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)
• balanced electrolyte solution
plasma adapted Ringer's solution

Locations

Country	Name	City	State
Germany	Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin	Berlin
Germany	Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum	Berlin
Germany	Universitätsklinikum Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First endpoint: Intraoperatively required amount of HES (10%, 6%) (ml)	Goal-directed (stroke volume) plasma volume therapy	up to 8 hours	No
Primary	Second endpoint: Time until fully on oral (solid) diet (days)		up to 15 days	No
Secondary	haemodynamics, arterial blood gas analysis, laboratory data, postoperative nausea and vomiting, adverse events, nursing delirium screening scale, several injury scores		up to 7 days	Yes