Plasma Volume Replacement (PVR) Therapy With Colloid and... | NCT01117649

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

NCT01117649

Sponsor

B. Braun Melsungen AG

Status

Completed

Last Update Posted

Dec 23, 2016Estimated

Enrollment

63Actual

Phase

Phase 4

Conditions

Plasma Volume Replacement
Surgery of the Pancreatic Head

Interventions

HES 10%
HES 6%
balanced electrolyte solution

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jul 2012Actual

Completion Date

Jul 2013Actual

First Submitted Date

Apr 28, 2010

First Submission Date that Met QC Criteria

May 4, 2010

First Posted Date

May 5, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2016

Last Update Posted Date

Dec 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

63Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	hyper-oncotic colloid	Drug: HES 10%
2	Active Comparator	iso-oncotic colloid	Drug: HES 6%
3	Active Comparator	crystalloid	Drug: balanced electrolyte solution

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HES 10%	Drug	HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).	1

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia Spies, Prof. Dr.	Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin, Campus Virchow-Klinikum	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin		Berlin		13353	Germany