Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch (FLASH Study)

Summary

The primary purpose of the study is to evaluate whether the type of fluid (0.9% saline or 6% Hydroxyethyl starch 130/0.4) in the context of an individualized goal-directed fluid therapy is associated with a difference in morbidity and mortality within the first 14 days in patients at moderate-to-high risk of postoperative complications after abdominal surgery.

Conditions

• Postoperative Morbidity
• Postoperative Mortality

Interventions

DRUG

Hydroxethyl starch

Sponsors & Collaborators

• Agence Nationale de sécurité du Médicament

  collaborator OTHER

• Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier)

  collaborator UNKNOWN

• Société Française Anesthesie-Réanimation (SFAR)

  collaborator UNKNOWN

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Emmanuel FUTIER · University Hospital, Clermont-Ferrand

• Jean-Etienne BAZIN · University Hospital, Clermont-Ferrand

• Samir JABER · University Hospital, Montpellier

• Julien POTTECHER · CHRU Strasbourg

• Alexandre OUATTARA · University Hospital, Bordeaux

• Thomas LESCOT · Hôpital Saint-Antoine (APHP)

• Hélène BELOEIL · CHU Rennes

• Gilles LEBUFFE · CHRU LILLE

• Philippe CUVILLON · CHU Nîmes

• Julien BUREY · Hôpital Tenon (APHP)

• Willy-Serge MFAM · CH ORLEANS

• Vincent PIRIOU · Hospices Civils de Lyon

• Marc LEONE · AP-HM

• Sébastien BERTRAN · CHU Nîmes

• Marion FAUCHER · Institut Paoli-Calmettes

• Catherine PAUGAM-BURTZ · Hôpital Beaujon

• Lionel VELLY · AP-HM

• Olivier HUET · CHU Brest

• Sigismond LASOCKI · University Hospital, Angers

• Pierre SAINT-LEGER · CH VALENCIENNES

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-02-29

Primary Completion

2018-07-22

Completion

2018-10-22

Countries

• France

Study Locations