NCT00968565

Brief Summary

The purpose of this study is to determine the safety and efficacy of citrate to provide anticoagulation of an ECMO circuit without patient anticoagulation. The standard method of providing ECMO circuit anticoagulation is the use of heparin which also anticoagulates the patient and increases the risk of patient bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jan 2010

Longer than P75 for early_phase_1

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

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 3, 2015

Status Verified

June 1, 2010

Enrollment Period

5.4 years

First QC Date

August 28, 2009

Last Update Submit

June 1, 2015

Conditions

Heart Defects, CongenitalRespiratory Insufficiency

Keywords

Heart Defects, CongenitalExtracorporeal Membrane OxygenationCitric AcidHeparinRespiratory Insufficiency

Outcome Measures

Primary Outcomes (1)

  • anticoagulation of ECMO circuit while maintaining normal coagulation and calcium levels in patient

    hourly

Secondary Outcomes (1)

  • Maintain normal serum calcium levels in patients

    hourly

Study Arms (1)

Citrate

EXPERIMENTAL

Sodium citrate will be infused as the blood enters the ECMO circuit and calcium chloride will be infused as the blood leaves the ECMO circuit and enters the patient

Drug: sodium citrate

Interventions

sodium citrateDRUG

Continuous infusion of 4% sodium citrate at 300 ml/hour into ECMO circuit

Citrate

Eligibility Criteria

Age1 Day - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infant less than one year of age and less than 6 kg
  • Informed consent obtained from parent
  • One or more of the following diagnoses:
  • Post-op congenital heart surgery
  • Congenital diaphragmatic hernia
  • Sepsis with coagulopathy not corrected prior to ECMO
  • Other newborn diagnosis with Grade I or II IVH
  • Infant requires/is on ECMO

You may not qualify if:

  • Consent denied or unobtainable
  • Age greater than one year
  • Weight greater than 6 kg
  • Gestational age less than 34 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Children's Hospital

Nashville, Tennessee, 37232, United States

Location

Related Publications (4)

  • Pinnick RV, Wiegmann TB, Diederich DA. Regional citrate anticoagulation for hemodialysis in the patient at high risk for bleeding. N Engl J Med. 1983 Feb 3;308(5):258-61. doi: 10.1056/NEJM198302033080506. No abstract available.

    PMID: 6848936BACKGROUND

  • Bagshaw SM, Laupland KB, Boiteau PJ, Godinez-Luna T. Is regional citrate superior to systemic heparin anticoagulation for continuous renal replacement therapy? A prospective observational study in an adult regional critical care system. J Crit Care. 2005 Jun;20(2):155-61. doi: 10.1016/j.jcrc.2005.01.001.

    PMID: 16139156BACKGROUND

  • Suzuki Y, Yamauchi S, Daitoku K, Fukui K, Fukuda I. Extracorporeal membrane oxygenation circulatory support after congenital cardiac surgery. ASAIO J. 2009 Jan-Feb;55(1):53-7. doi: 10.1097/MAT.0b013e31818f0056.

    PMID: 19092671BACKGROUND

  • Clark JA, Schulman G, Golper TA. Safety and efficacy of regional citrate anticoagulation during 8-hour sustained low-efficiency dialysis. Clin J Am Soc Nephrol. 2008 May;3(3):736-42. doi: 10.2215/CJN.03460807. Epub 2008 Feb 13.

    PMID: 18272829BACKGROUND

MeSH Terms

Conditions

Heart Defects, CongenitalRespiratory Insufficiency

Interventions

Sodium Citrate

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesRespiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Citric AcidCitratesTricarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • John B Pietsch, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatric Surgery and Pediatrics

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

January 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 3, 2015

Record last verified: 2010-06

Locations

US(1)