Indication for Intraoperative Volume Therapy | NCT01454258

Studies
Indication for Intraoperative Volume Therapy

NCT01454258

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Completed

Last Update Posted

Sep 14, 2017Actual

Enrollment

10,100Actual

Phase

Not provided

Conditions

Patients Undergoing Any Kind of Surgery

Interventions

Not provided

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

Participant Flow Module

Pre-assignment Details

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

Aug 2017

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

Oct 2011

Primary Completion Date

Dec 2012Actual

Completion Date

Mar 2013Actual

First Submitted Date

Oct 14, 2011

First Submission Date that Met QC Criteria

Oct 14, 2011

First Posted Date

Oct 18, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Apr 2, 2015

Results First Submitted that Met QC Criteria

Nov 5, 2015

Results First Posted Date

Dec 7, 2015Estimated

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

Aug 15, 2017

Last Update Posted Date

Sep 14, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Professor Kai Zacharowski, M.D., Ph.D., FRCA, Director, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Description Module

Brief Summary

This study evaluates which substitution solutions are used in daily clincal practice in various teaching hospitals in a specific district (Frankfurt/Rhine-Main Metropolitan Region). Furthermore the indication for usage of these solutions is investigated.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10,100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Different Substitution Solutions Administered		24h

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing surgery receiving at least one bag of cristalloid or colloid solution

Exclusion Criteria:

decline of participation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients of participating hospitals that will undergo surgery and receive intravenous fluid or volume treatment(cristalloid or colloid) will be included.

Participating hospitals are the university teaching hospitals of the Goethe University Hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kai Zacharowski, MD, PhD	Johann Wolfgang Goethe University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Goethe University Hospital		Frankfurt am Main	Hesse	60590	Germany

ID	Title	Description
FG000	Cohort	Surgical patients from 10 hospitals over a period of 13 months

Baseline Characteristics Module

Baseline Analysis Population Description

Not provided

Type of Units Analyzed

Not provided

Arm/Group Information

ID	Title	Description
BG000	Cohort	Surgical patients from 10 hospitals over a period of 13 months

Denominators

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Number

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Different Substitution Solutions Administered

Surgical patients from 10 hospitals over a period of 13 months

Posted

Number

participants

24h

ID	Title	Description
OG000	Crystalloids	crystalloids
OG001	Hydroxyethyl Starch	HES
OG002	Other Colloids	gelatine, albumin,

Adverse Events Module

Frequency Threshold

Time Frame

Not provided

Description

Not provided

All-Cause Mortality Comment

Not provided

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort	Surgical patients

Serious Adverse Events

Not provided

Other Adverse Events

Not provided

More Info Module

Limitations and Caveats

Not provided

Certain Agreements

Are all PI(s) employees of the sponsor?

Restriction Type

Point of Contact

Title	Organization	Phone	Extension	Email
Prof Dr Dr Kai Zacharowski, FRCA	University Hospital Frankfurt	004969630186668		kai.zacharowski@kgu.de