Postoperative MorbidityPhase 3FLASHNCT02502773
Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch (FLASH Study)
A Phase 3 study testing Hydroxethyl starch in people with Postoperative Morbidity and Postoperative Mortality, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Morbidity, Postoperative Mortality
- What is being tested?
- Hydroxethyl starch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 826 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2016to 22 Oct 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)
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.
Read the 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.
- Conditions
- Postoperative Morbidity, Postoperative Mortality
- Being tested
- Hydroxethyl starch
- Keywords
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxethyl starchDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Hydroxethyl starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal dysfunction
Renal dysfunction (defined by KDIGO stage 1 or higher)
Measured: 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)
Measured: during the first 14 postoperative days
Cardiovascular complication
Cardiovascular complication (defined by the development of acute heart failure)
Measured: during the first 14 postoperative days
Infectious complication
Infectious complication (defined by the development of sepsis, severe sepsis or septic shock)
Measured: during the first 14 postoperative days
Surgical complication
Surgical complication (defined as the need for surgical reoperation)
Measured: during the first 14 postoperative days
Secondary outcomes (16)
Total fluid volume
Total fluid volume (0.9% saline and HES 130/0.4)
Measured: during the surgical period and the first 24 postoperative hours
Volume of blood loss
Measured: during the surgical period and the first 24 postoperative hours
Renal complications : oliguria
Postoperative complications
Measured: within 14 days
Cardiovascular complications
Postoperative complications
Measured: within 14 days
Respiratory complications
Postoperative complications
Measured: within 14 days
SIRS score
Postoperative complications
Measured: within 14 days
Infectious complications
Postoperative complications
Measured: within 14 days
Surgical complications
Postoperative complications
Measured: within 14 days
Severity organ failure assessment score from postoperative
Measured: Day-1 to Day-7
Unexpected ICU admission (or readmission) following surgery
Measured: within 28 days
All-cause mortality
Measured: 28 days
All-cause mortality
Measured: 3 months
Serum lactate
Measured: from Day-1 to Day-7
C-reactive protein
Measured: from Day-1 to Day-7
Plasma chloride
Measured: from Day-1 to Day-7
number of units of packed red blood cells
Measured: during the surgical period and the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startFeb 2016
- Primary completion22 Jul 2018
- Study completion22 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative MorbidityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 826 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Agence Nationale de sécurité du Médicament, Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier), Société Française Anesthesie-Réanimation (SFAR)
- Responsible party
- Sponsor
- Investigators
- Emmanuel FUTIER, Principal investigator, University Hospital, Clermont-FerrandJean-Etienne BAZIN, Principal investigator, University Hospital, Clermont-FerrandSamir JABER, Principal investigator, University Hospital, MontpellierJulien POTTECHER, Principal investigator, CHRU StrasbourgAlexandre OUATTARA, Principal investigator, University Hospital, BordeauxThomas LESCOT, Principal investigator, Hôpital Saint-Antoine (APHP)Hélène BELOEIL, Principal investigator, Rennes University HospitalGilles LEBUFFE, Principal investigator, CHRU LILLE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502773
- Sponsor's protocol ID
- CHU-0242
- Other IDs
- 2014-005575-84, 2014
- Acronym
- FLASH
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2015
- Last updated
- 5 Aug 2026
- Results posted
- No
Publications
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.
PubMed 31961418Futier 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.
PubMed 26690683
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)
- ClinicalTrials.gov ID
- NCT02502773
- Acronym / sponsor ID
- FLASH / CHU-0242
- Conditions
- Postoperative Morbidity, Postoperative Mortality
- Keywords
- Goal-directed therapy, Fluid loading, Abdominal surgery, Postoperative morbidity, Postoperative mortality, Individualized goal-directed fluid therapy, Elective or emergency abdominal surgery, General Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 826 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Agence Nationale de sécurité du Médicament, Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier), Société Française Anesthesie-Réanimation (SFAR)
- Study start
- Feb 2016 (actual)
- Primary completion
- 22 Jul 2018 (actual)
- Study completion
- 22 Oct 2018 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crystalloid group | Experimental | Drug: Hydroxethyl starchThe 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 | Drug: Hydroxethyl starchThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydroxethyl starch | Drug | colloid group, crystalloid group |
Primary outcome
Renal dysfunction
Time frame: during the first 14 postoperative days
Renal dysfunction (defined by KDIGO stage 1 or higher)
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)
Cardiovascular complication
Time frame: during the first 14 postoperative days
Cardiovascular complication (defined by the development of acute heart failure)
Infectious complication
Time frame: during the first 14 postoperative days
Infectious complication (defined by the development of sepsis, severe sepsis or septic shock)
Surgical complication
Time frame: during the first 14 postoperative days
Surgical complication (defined as the need for surgical reoperation)
16 secondary outcomes
Total fluid volume
Time frame: during the surgical period and the first 24 postoperative hours
Volume of blood loss
Time frame: during the surgical period and the first 24 postoperative hours
Renal complications : oliguria
Time frame: within 14 days
Cardiovascular complications
Time frame: within 14 days
Respiratory complications
Time frame: within 14 days
SIRS score
Time frame: within 14 days
Infectious complications
Time frame: within 14 days
Surgical complications
Time frame: within 14 days
Severity organ failure assessment score from postoperative
Time frame: Day-1 to Day-7
Unexpected ICU admission (or readmission) following surgery
Time frame: within 28 days
All-cause mortality
Time frame: 28 days
All-cause mortality
Time frame: 3 months
Serum lactate
Time frame: from Day-1 to Day-7
C-reactive protein
Time frame: from Day-1 to Day-7
Plasma chloride
Time frame: from Day-1 to Day-7
number of units of packed red blood cells
Time frame: during the surgical period and the first 24 postoperative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Results publication: PubMed 31961418Futier 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.
- Derived from this study: PubMed 26690683Futier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel FUTIER principal investigator
University Hospital, Clermont-Ferrand
Jean-Etienne BAZIN principal investigator
University Hospital, Clermont-Ferrand
Samir JABER principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydroxethyl starch in people with Postoperative Morbidity and Postoperative Mortality, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal dysfunction (time frame: during the first 14 postoperative days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502773, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.