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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005575-84 | EudraCT Number |
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| Name | Class |
|---|---|
| Agence Nationale de sécurité du Médicament | OTHER |
| Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier) | UNKNOWN |
| Société Française Anesthesie-Réanimation (SFAR) | UNKNOWN |
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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxethyl starch | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total fluid volume | Total fluid volume (0.9% saline and HES 130/0.4) | during the surgical period and the first 24 postoperative hours |
| Volume of blood loss | during the surgical period and the first 24 postoperative hours |
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Inclusion Criteria:
All adult patients who
Exclusion Criteria:
The following patients will not be evaluated for inclusion:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Rennes University Hospital | Principal Investigator |
| Gilles LEBUFFE | CHRU LILLE | Principal Investigator |
| Philippe CUVILLON | CHU Nîmes | Principal Investigator |
| Julien BUREY | Hôpital Tenon (APHP) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31961418 | Derived | 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. | |
| 26690683 |
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| Renal complications : oliguria | Postoperative complications | within 14 days |
| Cardiovascular complications | Postoperative complications | within 14 days |
| Respiratory complications | Postoperative complications | within 14 days |
| SIRS score | Postoperative complications | within 14 days |
| Infectious complications | Postoperative complications | within 14 days |
| Surgical complications | Postoperative complications | within 14 days |
| Severity organ failure assessment score from postoperative | Day-1 to Day-7 |
| Unexpected ICU admission (or readmission) following surgery | within 28 days |
| All-cause mortality | 28 days |
| All-cause mortality | 3 months |
| Serum lactate | from Day-1 to Day-7 |
| C-reactive protein | from Day-1 to Day-7 |
| Plasma chloride | from Day-1 to Day-7 |
| number of units of packed red blood cells | during the surgical period and the first 24 postoperative hours |
| 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 |
| Derived |
| 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. |