GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery

NCT ID: NCT01401283

Last Updated: 2016-02-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study group

intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation, measurement of cardiac output and pulse pressure variation, hemodynamic optimization according to cardiac index and pulse pressure variation

Group Type ACTIVE_COMPARATOR

measurement of cardiac output and pulse pressure variation

Intervention Type DEVICE

hemodynamic optimization according to cardiac index and pulse pressure variation

Control group

hemodynamic management according to institutional clinical standards

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

measurement of cardiac output and pulse pressure variation

hemodynamic optimization according to cardiac index and pulse pressure variation

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* major abdominal surgery
* duration of surgery \> 2 hours

Exclusion Criteria

* age \< 18 years
* scheduled postoperative icu treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northern State Medical University

OTHER

Sponsor Role collaborator

Szeged University

OTHER

Sponsor Role collaborator

University of Kiel

OTHER

Sponsor Role collaborator

University of Witten/Herdecke

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel A Reuter, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Medical Center Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.

Reference Type DERIVED
PMID: 24010849 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

797726

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CNAP in Heart Surgery
NCT01420484 COMPLETED