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Influence de la vitesse de perfusion du sérum salé hypertonique/hydroxyethylamidon sur l’hémodynamique systémique au cours du choc septique et hémorragique.

Influence de la vitesse de perfusion du sérum salé hypertonique/hydroxyethylamidon sur l’hémodynamique systémique au cours du choc septique et hémorragique.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-001475-11-FR
Enrollment
Unknown
Registered
2007-05-10
Start date
2007-10-09
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SHOCK HYPOVOLEMIQUE OF SEPTIC OR HAEMORRHAGIC ORIGIN

Interventions

Trade Name: HyperHes® Product Name: hyperHes® Pharmaceutical Form: Solution for injection INN or Proposed INN: hydroxyéthylamidon 200 000 Concentration unit: g/l gram(s)/litre Concentration type: equa

Sponsors

Assistance Publique Hopitaux de marseille
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: PATIENTS PRESENTING A HYPOVOLEMIE AIGUE WHITIN THE FRAMEWORK OF A TOXIC SHOCK OR A HAEMORRHAGIC SHOCK Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patient of less than 18 years Pregnancy Absence of assent Patient at the end of life evolved Cardiac insufficiency (NYHA III or IV) Allergy known about the hydroxyethylamidon Hypernatrémie = 150mmol / L

Design outcomes

Primary

MeasureTime frame
Main Objective: Evaluation of the variation of the Blood pressure Averages according to the speed of drip.;Secondary Objective: ESTIMATE OF THE VARIATION OF the CARDIAC OUTPUT ACCORDING TO THE SPEED OF DRIP OF THE OXYGENATION BY CALCULATION OF the REPORT PAO2/FIO2 ESTIMATE OF THE NATREMIE;OF THE CHLOREMIE AND the ARTERIAL PH;Primary end point(s): The tested hypothesis is the absence of significant variations of the average blood pressure hanging and after the administration of HyperHES ® in the group with slow drip (30 minutes) with regard to the values of bases, and the existence of a significant decrease of the average blood pressure hanging in the group receiving HyperHES ® by fast drip (5 minutes) compared with the basic values and with the group with slow drip.

Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026