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Clinical Trials/NCT01117519
NCT01117519
Completed
Phase 4

Impact of a Balanced Infusion Solution Compound of 50% Crystalloid and 50% Colloid Versus an Unbalanced Infusion Solution of 100% Crystalloid Within a Goal-directed Hemodynamic Protocol on Acid-base Balance

Charite University, Berlin, Germany1 site in 1 country40 target enrollmentStarted: May 2010Last updated:
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ConditionsHemodynamic Instability
InterventionsInfusion Therapy
DrugsInfusion Therapy

Overview

Phase
Phase 4
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Standard Base Excess
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

The purpose of this study is to determine whether the administration of a compound of balanced infusion solutions including 50% crystalloid and 50% colloid has a positive impact on acid-base balance in elective hip replacement surgery. The application of the study medication will be carried out through a goal-directed intraoperative therapy by transoesophageal doppler.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients at the age of 60 and above who want to undergo an elective hip replacement surgery in the center of musculoskeletal surgery
  • •Offered patient information and written informed consent

Exclusion Criteria

  • •Participation in another trial according to the German Drug Law 30 days to and during the study
  • •Lacking willingness to save and hand out data within the study
  • •Accommodation in an institution due to an official or judicial order
  • •(Unclear) history of alcohol or substances disabuse
  • •Absent knowledge of german language
  • •Analphabetism
  • •Allergy to hydroxyethyl starch or other ingredients of the intravenous solutions
  • •For women: Pregnancy or positive pregnancy test within the preoperative screening
  • •Operation due to case of emergency, polytrauma or pathologic fracture
  • •Only use of regional anaesthesia

Arms & Interventions

unbalanced infusion solution

Active Comparator

Intervention: Infusion Therapy (Drug)

balanced infusion solution compound

Active Comparator

Intervention: Infusion Therapy (Drug)

Outcomes

Primary Outcomes

Standard Base Excess

Time Frame: up to 2 days

After administration of 2 litres of study medication. In recovery room. On general ward.

Secondary Outcomes

  • Discharge Criteria, Length of Hospital Stay(5 days up to hospital discharge)
  • SID (strong ion difference)(up to 2 days)
  • Hemodynamic Stability(up to 6 days)
  • Fluid Loss of Drainage(up to 6 days)
  • Organ Function/Dysfunction(up to 6 days)
  • Incidence of Infections(up to 5 days)
  • Pain(up to 6 days)
  • Mobilisation(up to 6 days)
  • Incidence of Delirium(up to 6 days)
  • Incidence of Postoperative Cognitive Deficit (POCD)(up to 90 days after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Claudia Spies

Prof. MD, Director of the Dept. of Anaesthesiology and Intensive Care Medicine, CVK, CCM

Charite University, Berlin, Germany

Study Sites (1)

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