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

NCT01117649 | Completed Phase 4

• 1 other identifier: HC-G-H-0803
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

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.

Conditions

Plasma Volume Replacement; Surgery of the Pancreatic Head

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 (1)

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

  up to 7 days

Study Arms (3)

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

HES 10% DRUG

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

1

HES 6% DRUG

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

2

balanced electrolyte solution DRUG

plasma adapted Ringer's solution

3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (3)

Klinik für Anästhesie und operative Intensivmedizin, Charité-Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Klinik für Anästhesie, operative Intensivmedizin und Schmerztherapie, Humboldt Klinikum

Berlin, 13509, Germany

Location

Universitätsklinikum Bonn

Bonn, 53127, Germany

Location

MeSH Terms

Interventions

HES 130-0.42-6:1

Study Officials

• Claudia Spies, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: May 5, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2013
• Last Updated: December 23, 2016

Record last verified: 2016-12

Locations

DE (3)