NCT02502773

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
826

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2016

Typical duration for phase_3

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

July 13, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 20, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2018

Completed
Last Updated

February 21, 2019

Status Verified

February 1, 2019

Enrollment Period

2.5 years

First QC Date

July 13, 2015

Last Update Submit

February 20, 2019

Conditions

Postoperative MorbidityPostoperative Mortality

Keywords

Goal-directed therapyFluid loadingAbdominal surgeryPostoperative morbidityPostoperative mortalityIndividualized goal-directed fluid therapyElective or emergency abdominal surgeryGeneral AnesthesiaModerate-to-high risk surgical patients

Outcome Measures

Primary Outcomes (5)

  • Renal dysfunction

    Renal dysfunction (defined by KDIGO stage 1 or higher)

    during the first 14 postoperative days

  • Pulmonary complication

    Pulmonary complication (defined by the need for noninvasive or invasive ventilatory assistance for postoperative acute respiratory failure)

    during the first 14 postoperative days

  • Cardiovascular complication

    Cardiovascular complication (defined by the development of acute heart failure)

    during the first 14 postoperative days

  • Infectious complication

    Infectious complication (defined by the development of sepsis, severe sepsis or septic shock)

    during the first 14 postoperative days

  • Surgical complication

    Surgical complication (defined as the need for surgical reoperation)

    during the first 14 postoperative days

Secondary Outcomes (16)

  • Total fluid volume

    during the surgical period and the first 24 postoperative hours

  • Volume of blood loss

    during the surgical period and the first 24 postoperative hours

  • Renal complications : oliguria

    within 14 days

  • Cardiovascular complications

    within 14 days

  • Respiratory complications

    within 14 days

  • +11 more secondary outcomes

Study Arms (2)

crystalloid group

EXPERIMENTAL

The proposed Flash multicenter study will be conducted to assess if the use of HES or crystalloid solutions during an individualized GDT contribute to outcome differences in patients at moderate-to-high risk of postoperative complications after abdominal surgery

Drug: Hydroxethyl starch

colloid group

EXPERIMENTAL

The proposed Flash multicenter study will be conducted to assess if the use of HES or crystalloid solutions during an individualized GDT contribute to outcome differences in patients at moderate-to-high risk of postoperative complications after abdominal surgery

Drug: Hydroxethyl starch

Interventions

Hydroxethyl starchDRUG
colloid groupcrystalloid group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (2)

  • Futier E, Garot M, Godet T, Biais M, Verzilli D, Ouattara A, Huet O, Lescot T, Lebuffe G, Dewitte A, Cadic A, Restoux A, Asehnoune K, Paugam-Burtz C, Cuvillon P, Faucher M, Vaisse C, El Amine Y, Beloeil H, Leone M, Noll E, Piriou V, Lasocki S, Bazin JE, Pereira B, Jaber S; FLASH Trial Group; Lasocki S, Huet O, Cadic A, Jacob C, Paugam-Burtz C, Restoux A, Ouattara A, Feitita I, Deloge E, Defaye M, Joannes-Boyau O, Carles P, Napolitano G, Monziols S, Futier E, Vignaud M, Paul S, Gahbiche K, Fayon J, Laroche E, Bazin JE, Brandely A, Le Moal C, Lebuffe G, Garot M, Piriou V, Jaber S, Chanques G, Verzilli D, De Jong A, Millot A, Castagnoli A, Leone M, Pastene B, Castelli C, Medam S, Velly L, Vaisse C, Faucher M, Asehnoune K, Samba E, Roquilly A, Le Penndu M, Cuvillon P, Yves Lefrant J, Wira O, Dubout E, Mfam WS, Lescot T, Begneu E, Burey J, Cirilovic T, Beloeil H, Allo G, Pottecher J, Lebas B, Venot C, Rameau JP, Dimache F, Leger PS, El Amine Y. Effect of Hydroxyethyl Starch vs Saline for Volume Replacement Therapy on Death or Postoperative Complications Among High-Risk Patients Undergoing Major Abdominal Surgery: The FLASH Randomized Clinical Trial. JAMA. 2020 Jan 21;323(3):225-236. doi: 10.1001/jama.2019.20833.

    PMID: 31961418DERIVED

  • Futier E, Biais M, Godet T, Bernard L, Rolhion C, Bourdier J, Morand D, Pereira B, Jaber S; FLASH trial management committee. Fluid loading in abdominal surgery - saline versus hydroxyethyl starch (FLASH Trial): study protocol for a randomized controlled trial. Trials. 2015 Dec 21;16:582. doi: 10.1186/s13063-015-1085-3.

    PMID: 26690683DERIVED

Study Officials

  • Emmanuel FUTIER

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

  • Jean-Etienne BAZIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

  • Samir JABER

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

  • Julien POTTECHER

    CHRU Strasbourg

    PRINCIPAL INVESTIGATOR

  • Alexandre OUATTARA

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Thomas LESCOT

    Hôpital Saint-Antoine (APHP)

    PRINCIPAL INVESTIGATOR

  • Hélène BELOEIL

    CHU Rennes

    PRINCIPAL INVESTIGATOR

  • Gilles LEBUFFE

    CHRU LILLE

    PRINCIPAL INVESTIGATOR

  • Philippe CUVILLON

    CHU Nîmes

    PRINCIPAL INVESTIGATOR

  • Julien BUREY

    Hôpital Tenon (APHP)

    PRINCIPAL INVESTIGATOR

  • Willy-Serge MFAM

    CH ORLEANS

    PRINCIPAL INVESTIGATOR

  • Vincent PIRIOU

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

  • Marc LEONE

    AP-HM

    PRINCIPAL INVESTIGATOR

  • Sébastien BERTRAN

    CHU Nîmes

    PRINCIPAL INVESTIGATOR

  • Marion FAUCHER

    Institut Paoli-Calmettes

    PRINCIPAL INVESTIGATOR

  • Catherine PAUGAM-BURTZ

    Hôpital Beaujon

    PRINCIPAL INVESTIGATOR

  • Lionel VELLY

    AP-HM

    PRINCIPAL INVESTIGATOR

  • Olivier HUET

    CHU Brest

    PRINCIPAL INVESTIGATOR

  • Sigismond LASOCKI

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

  • Pierre SAINT-LEGER

    CH VALENCIENNES

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2015

First Posted

July 20, 2015

Study Start

February 1, 2016

Primary Completion

July 22, 2018

Study Completion

October 22, 2018

Last Updated

February 21, 2019

Record last verified: 2019-02

Locations

FR(1)