NCT01662141

Brief Summary

The measurement of cardiac output (CO) and hemodynamic pressures are vital for proper management of severely hemodynamic compromised patients. A new ultrasound dilution method (COstatus) for cardiac output measurement has been developed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2010

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

February 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 10, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

1.6 years

First QC Date

August 6, 2012

Last Update Submit

August 7, 2012

Conditions

Post Cardiac Surgery

Keywords

Cardiac outputPerivascular Probe

Outcome Measures

Primary Outcomes (1)

  • Measurement of cardiac output by a new ultrasound dilution method in mechanically ventilated children after pediatric cardiac surgery.

    To compare cardiac outputs measured with this new ultrasound dilution method with flowmetry (perivascular probe) using ultrasound transit time measured directly on the aorta in children \< 15 kg of weight. Also to assess reliability of COstatus measurements in pediatric patients.

    Measurements are made during a patient's stay with insitu catheters. The expected average stay is 3-4 days.

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric Patients (\< 15) in the ICU

You may qualify if:

  • Children \<15 kg admitted to pediatric cardiac surgery for corrective surgery and mechanically ventilated were eligible for the study if parents provided informed consent.

You may not qualify if:

  • Children with known significant tricuspid or mitral valve regurgitations or if it is detected by the preoperative transesophageal echocardiographic examination.
  • Children with persistent severe arrhythmias.
  • Children with remaining intracardiac shunts after surgery, which may adversely affect the measurement.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital, BUS, BIVA

Lund, SE-221 85, Sweden

Location

Related Publications (1)

  • Krivitski NM, Kislukhin VV, Thuramalla NV. Theory and in vitro validation of a new extracorporeal arteriovenous loop approach for hemodynamic assessment in pediatric and neonatal intensive care unit patients. Pediatr Crit Care Med. 2008 Jul;9(4):423-8. doi: 10.1097/01.PCC.0b013e31816c71bc.

    PMID: 18496416BACKGROUND

Study Officials

  • Lars Lindberg, MD, PhD

    University Hospital in Lund

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2012

First Posted

August 10, 2012

Study Start

February 1, 2010

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

August 10, 2012

Record last verified: 2012-08

Locations

SE(1)