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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02502773
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
Agence Nationale de sécurité du Médicament
Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier)
Société Française Anesthesie-Réanimation (SFAR)
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Postoperative Morbidity Postoperative Mortality Drug: Hydroxethyl starch Phase 3

Detailed Description:

Fluid administration is the mainstay treatment for suspected hypovolemia during surgery, but the effects of different crystalloid and colloid solutions on outcome remain poorly explored in surgical patients.

Two recent international multicenter studies (6S and CHEST studies) have shown that, compared to crystalloid solutions, the use of hydroxyethyl starch (HES) could be responsible for higher morbidity, especially renal failure, and mortality in ICU patients, thus leading to a recent restriction of their range of indications.

In contrast, in surgical patients, recent meta-analyses have concluded on the absence of difference in terms of mortality and postoperative renal failure between crystalloids and latest generation HES. Excessive fluid administration during surgery is associated with increased risk of postoperative morbidity, including renal dysfunction and mortality. It has been suggested that, compared with the volume-restoring effects of colloids, crystalloid use may require the administration of higher fluid volumes, which may contribute to poorer outcomes. In the surgical context, clinical trials and meta-analyses have shown that individualized goal-direct fluid administration can reduce postoperative morbidity. Although most GDT studies have used colloid solutions for fluid loading, the effects of the type of fluids are currently unknown and crystalloids are proposed for first-line therapy.

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. As these fluids are widely used during surgery and because of current concerns about the risks related to the use of HES-based products in ICU patients, the trial will provide important data to clinicians involved in perioperative care.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 826 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)
Actual Study Start Date : February 2016
Actual Primary Completion Date : July 22, 2018
Actual Study Completion Date : October 22, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Starch

Arm Intervention/treatment
Experimental: crystalloid group
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
Experimental: colloid group
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



Primary Outcome Measures :
  1. Renal dysfunction [ Time Frame: during the first 14 postoperative days ]
    Renal dysfunction (defined by KDIGO stage 1 or higher)

  2. Pulmonary complication [ Time Frame: during the first 14 postoperative days ]
    Pulmonary complication (defined by the need for noninvasive or invasive ventilatory assistance for postoperative acute respiratory failure)

  3. Cardiovascular complication [ Time Frame: during the first 14 postoperative days ]
    Cardiovascular complication (defined by the development of acute heart failure)

  4. Infectious complication [ Time Frame: during the first 14 postoperative days ]
    Infectious complication (defined by the development of sepsis, severe sepsis or septic shock)

  5. Surgical complication [ Time Frame: during the first 14 postoperative days ]
    Surgical complication (defined as the need for surgical reoperation)


Secondary Outcome Measures :
  1. Total fluid volume [ Time Frame: during the surgical period and the first 24 postoperative hours ]
    Total fluid volume (0.9% saline and HES 130/0.4)

  2. Volume of blood loss [ Time Frame: during the surgical period and the first 24 postoperative hours ]
  3. Renal complications : oliguria [ Time Frame: within 14 days ]
    Postoperative complications

  4. Cardiovascular complications [ Time Frame: within 14 days ]
    Postoperative complications

  5. Respiratory complications [ Time Frame: within 14 days ]
    Postoperative complications

  6. SIRS score [ Time Frame: within 14 days ]
    Postoperative complications

  7. Infectious complications [ Time Frame: within 14 days ]
    Postoperative complications

  8. Surgical complications [ Time Frame: within 14 days ]
    Postoperative complications

  9. Severity organ failure assessment score from postoperative [ Time Frame: Day-1 to Day-7 ]
  10. Unexpected ICU admission (or readmission) following surgery [ Time Frame: within 28 days ]
  11. All-cause mortality [ Time Frame: 28 days ]
  12. All-cause mortality [ Time Frame: 3 months ]
  13. Serum lactate [ Time Frame: from Day-1 to Day-7 ]
  14. C-reactive protein [ Time Frame: from Day-1 to Day-7 ]
  15. Plasma chloride [ Time Frame: from Day-1 to Day-7 ]
  16. number of units of packed red blood cells [ Time Frame: during the surgical period and the first 24 postoperative hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502773


Locations
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France
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Agence Nationale de sécurité du Médicament
Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier)
Société Française Anesthesie-Réanimation (SFAR)
Investigators
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Principal Investigator: 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 CHU 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 CHU 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Léger 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.

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02502773    
Other Study ID Numbers: CHU-0242
2014-005575-84 ( EudraCT Number )
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: February 2019
Keywords provided by University Hospital, Clermont-Ferrand:
Goal-directed therapy
Fluid loading
Abdominal surgery
Postoperative morbidity
Postoperative mortality
Individualized goal-directed fluid therapy
Elective or emergency abdominal surgery
General Anesthesia
Moderate-to-high risk surgical patients