A Phase 3 interventional study of Hydroxethyl starch in Postoperative Morbidity and Postoperative Mortality, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University Hospital, Clermont-Ferrand · Phase 3, Interventional, and Treatment
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.
University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
The following patients will not be evaluated for inclusion:
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
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
Renal dysfunction
Renal dysfunction (defined by KDIGO stage 1 or higher)
Time frame: 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)
Time frame: during the first 14 postoperative days
Cardiovascular complication
Cardiovascular complication (defined by the development of acute heart failure)
Time frame: during the first 14 postoperative days
Infectious complication
Infectious complication (defined by the development of sepsis, severe sepsis or septic shock)
Time frame: during the first 14 postoperative days
Surgical complication
Surgical complication (defined as the need for surgical reoperation)
Time frame: during the first 14 postoperative days
Total fluid volume
Total fluid volume (0.9% saline and HES 130/0.4)
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
Postoperative complications
Time frame: within 14 days
Cardiovascular complications
Postoperative complications
Time frame: within 14 days
Respiratory complications
Postoperative complications
Time frame: within 14 days
SIRS score
Postoperative complications
Time frame: within 14 days
Infectious complications
Postoperative complications
Time frame: within 14 days
Surgical complications
Postoperative 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
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand