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Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.

Information source: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vasoplegic Syndrome

Intervention: Norepinephrine (Drug); Norepinephrine (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Centre Hospitalier Universitaire, Amiens

Official(s) and/or principal investigator(s):
Pierre-Grégoire Guinot, Doctor, Principal Investigator, Affiliation: CHU Amiens-Picardie

Overall contact:
Pierre-Grégoire Guinot, Doctor, Phone: 322455885, Ext: +33, Email: guinot.pierregregoire@chu-amiens.fr

Summary

After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound hypotension associated with a decrease in systemic vascular resistance. The care of this disease is based on the intravenous administration of a vasopressor, usually norepinephrine. During the recovery phase, weaning of norepinephrine, is an important step in which any lack of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.

Clinical Details

Official title: Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The duration of treatment with norepinephrine.

Secondary outcome:

The total dose of norepinephrine infused during the study period

ICU duration of stay in day

Total urine output in ml during the study period

Total of crystalloid an colloid infused during the study period (ml)

the rate of arterial lactate at the end of norepinephrine administration

Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period

SOFA score

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Major patient ≥ 18 years

- Patient operated a cardiac surgery for myocardial revascularization (CABG surgery) or

surgical correction of valvular or combined surgery (CABG and valve disease) or surgery the ascending aorta and cardiac surgery with vasoplegic syndrome treated by norepinephrine

- Signed consent

- Affiliation to social assurance

Exclusion Criteria:

- Permanent atrial fibrillation

- Treatment with dobutamine and/or epinephrine

- Pregnant woman

- Patient under guardianship or private public law

- Internal pacemaker

- Hypothermia

- Patient refusal

Locations and Contacts

Pierre-Grégoire Guinot, Doctor, Phone: 322455885, Ext: +33, Email: guinot.pierregregoire@chu-amiens.fr

CHU Amiens-Picardie, Amiens, Picardie 80054, France; Recruiting
Additional Information

Related publications:

Guinot PG, Bernard E, Levrard M, Dupont H, Lorne E. Dynamic arterial elastance predicts mean arterial pressure decrease associated with decreasing norepinephrine dosage in septic shock. Crit Care. 2015 Jan 19;19:14. doi: 10.1186/s13054-014-0732-5.

Starting date: October 2014
Last updated: June 23, 2015

Page last updated: August 23, 2015

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