NCT00549419

Brief Summary

The purpose of this study is to determine whether the early identification and more precise intervention of goal-directed intraoperative plasma volume expansion and catecholamine therapy using arterial pressure based cardiac output (APCO) measurement in addition to normal vital signs will improve postoperative organ function, in particular renal function, in patients undergoing major abdominal surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 25, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

December 23, 2009

Status Verified

January 1, 2009

Enrollment Period

1.3 years

First QC Date

October 23, 2007

Last Update Submit

December 21, 2009

Conditions

Major Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

  • The primary endpoint of the study is postoperative renal function, as determined by measurement of the glomerular filtration rate.

    6 month

Secondary Outcomes (1)

  • Total fluid requirements (type and volume); Drug requirement (type and volume); Other organ function (myocardial function, liver function, endothelial function, degree of inflammation)

    6 month

Study Arms (2)

1

EXPERIMENTAL

In the Treatment group, the traditional vital signs and APCO are made continuously available for fluid and catecholamine optimization and clinical decision making.

Drug: Goal-directed hemodynamic therapy

2

ACTIVE COMPARATOR
Drug: Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamineDrug: Standard of care

Interventions

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamineDRUG

The Control group will be assessed using the standard care of traditional vital signs

2
Goal-directed hemodynamic therapyDRUG

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

1
Standard of careDRUG

Ringers lactate, hydroxyethyl starch; norepinephrine, dobutamine

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is scheduled for elective major abdominal surgery and has two or more risk factors according to the Lee classification scheme.
  • Patient can sign informed consent before surgery.
  • Patient is able to comply with the study procedure.
  • Patient must require an indwelling radial or a femoral artery catheter.
  • Patient must be 20 years old or older.
  • Patient must be 40kg or heavier.
  • Patients height and weight can be accurately obtained prior to study start.

You may not qualify if:

  • Emergency surgery.
  • Patients with aortic or mitral valve regurgitation.
  • Renal insufficiency requiring hemodialysis.
  • Liver dysfunction (alanine/aspartate aminotransferase \>40 U/L).
  • Patient with contraindications for the placement of radial, femoral or other arterial cannulae.
  • Patient being treated with an intraaortic balloon pump.
  • Female patients with a known pregnancy.
  • Patient is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum Ludwigshafen

Ludwigshafen, RLP, 67063, Germany

Location

Related Publications (1)

  • Mayer J, Boldt J, Mengistu AM, Rohm KD, Suttner S. Goal-directed intraoperative therapy based on autocalibrated arterial pressure waveform analysis reduces hospital stay in high-risk surgical patients: a randomized, controlled trial. Crit Care. 2010;14(1):R18. doi: 10.1186/cc8875. Epub 2010 Feb 15.

    PMID: 20156348DERIVED

MeSH Terms

Interventions

Ringer's LactateHydroxyethyl Starch DerivativesNorepinephrineDobutamineStandard of Care

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsStarchDietary CarbohydratesCarbohydratesGlucansPolysaccharidesEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPhenethylaminesEthylaminesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Stefan W. Suttner, M.D. Ph.D.

    Klinikum Ludwigshafen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2007

First Posted

October 25, 2007

Study Start

October 1, 2007

Primary Completion

January 1, 2009

Study Completion

April 1, 2009

Last Updated

December 23, 2009

Record last verified: 2009-01

Locations

DE(1)