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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02502773
Date of registration:	13/07/2015
Prospective Registration:	Yes
Primary sponsor:	University Hospital, Clermont-Ferrand
Public title:	Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch (FLASH Study) FLASH
Scientific title:	Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)
Date of first enrolment:	February 2016
Target sample size:	826
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02502773
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
Phase:	Phase 3

Countries of recruitment
France

Contacts

Name:	Olivier HUET
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Affiliation:	CHU Brest

Name:	Lionel VELLY
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Affiliation:	AP-HM

Name:	Willy-Serge MFAM
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Affiliation:	CH ORLEANS

Name:	Vincent PIRIOU
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Affiliation:	CHU LYON

Name:	Thomas LESCOT
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Affiliation:	Hôpital Saint-Antoine (APHP)

Name:	Emmanuel FUTIER
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Affiliation:	University Hospital, Clermont-Ferrand

Name:	Pierre SAINT-LEGER
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Affiliation:	CH VALENCIENNES

Name:	Philippe CUVILLON
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Affiliation:	CHU Nîmes

Name:	Hélène BELOEIL
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Affiliation:	CHU Rennes

Name:	Marion FAUCHER
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Affiliation:	Institut Paoli-Calmettes

Name:	Marc LEONE
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Affiliation:	AP-HM

Name:	Alexandre OUATTARA
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Affiliation:	CHU Bordeaux

Name:	Catherine PAUGAM-BURTZ
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Affiliation:	Hôpital Beaujon

Name:	Julien BUREY
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Affiliation:	Hôpital Tenon (APHP)

Name:	Jean-Etienne BAZIN
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Affiliation:	University Hospital, Clermont-Ferrand

Name:	Gilles LEBUFFE
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Affiliation:	CHRU Lille

Name:	Julien POTTECHER
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Affiliation:	CHRU Strasbourg

Name:	Sébastien BERTRAN
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Affiliation:	CHU Nîmes

Name:	Sigismond LASOCKI
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Affiliation:	University Hospital, Angers

Name:	Samir JABER
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Affiliation:	University Hospital, Montpellier

Key inclusion & exclusion criteria

Inclusion Criteria:

All adult patients who

- Undergo elective or emergency abdominal surgery under general anesthesia

- With an estimated surgical duration greater than or equal to 2 hours

- With moderate-to-high risk of postoperative complications defined by an AKI risk
index= class 3, as defined by the presence of at least 4 of the following factors:
age> 56 years, male gender, intraperitoneal surgery, active congestive heart failure,
ascites, hypertension, emergency surgery, mild or moderate renal insufficiency,
diabetes mellitus treated by oral or insulin therapy

Exclusion Criteria:

The following patients will not be evaluated for inclusion:

- Age <18 years

- Preoperative acute heart failure

- Preoperative acute coronary insufficiency

- Preoperative severe renal failure (defined by creatinine clearance <30 ml/min or
requiring renal replacement therapy)

- Preoperative shock defined by the need for vasoactive amines

- History of allergy with the use of 6% Hydroxethyl starch 130/0.4

- Contraindication to the use of HES: sepsis, burnt patient, renal insufficiency or
dialysis, cerebral hemorrhage, ICU patient , hypervolemia, lung edema, dehydration,
severe hypernatremia or severe hyperchloremia, severe hepatic insufficiency,
congestive heart failure, severe coagulopathy, organ transplant

- Patient's or relative's refusal to participate

- Parturient or breastfeeding woman

- Protected major (guardianship)

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Postoperative Mortality

Postoperative Morbidity

Intervention(s)

Drug: Hydroxethyl starch

Primary Outcome(s)

Pulmonary complication [Time Frame: during the first 14 postoperative days]

Infectious complication [Time Frame: during the first 14 postoperative days]

Renal dysfunction [Time Frame: during the first 14 postoperative days]

Surgical complication [Time Frame: during the first 14 postoperative days]

Cardiovascular complication [Time Frame: during the first 14 postoperative days]

Secondary Outcome(s)

Volume of blood loss [Time Frame: during the surgical period and the first 24 postoperative hours]

Cardiovascular complications [Time Frame: within 14 days]

number of units of packed red blood cells [Time Frame: during the surgical period and the first 24 postoperative hours]

All-cause mortality [Time Frame: 3 months]

Infectious complications [Time Frame: within 14 days]

Plasma chloride [Time Frame: from Day-1 to Day-7]

Severity organ failure assessment score from postoperative [Time Frame: Day-1 to Day-7]

Surgical complications [Time Frame: within 14 days]

Unexpected ICU admission (or readmission) following surgery [Time Frame: within 28 days]

All-cause mortality [Time Frame: 28 days]

Respiratory complications [Time Frame: within 14 days]

SIRS score [Time Frame: within 14 days]

C-reactive protein [Time Frame: from Day-1 to Day-7]

Renal complications : oliguria [Time Frame: within 14 days]

Serum lactate [Time Frame: from Day-1 to Day-7]

Total fluid volume [Time Frame: during the surgical period and the first 24 postoperative hours]

Secondary ID(s)

CHU-0242

2014-005575-84

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Agence Nationale de sécurité du Médicament

Société Française Anesthesie-Réanimation (SFAR)

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

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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