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

Postoperative Morbidity Clinical Trial

— FLASH  

Official title:

Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch: A Double-blinded Multicenter Prospective Randomized Trial (FLASH Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02502773
• Other study ID #: CHU-0242
• Secondary ID: 2014-005575-84
• Status: Completed
• Phase: Phase 3
• Start date: February 2016
• Est. completion date: October 22, 2018

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 postoperative complications after abdominal surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 826
• Est. completion date: October 22, 2018
• Est. primary completion date: July 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Postoperative Morbidity
• Postoperative Mortality

Intervention

Drug:
• Hydroxethyl starch

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Agence Nationale de sécurité du Médicament, Programme Hospitalier de Recherche Clinique (AOI N° 2013 _ Futier), Société Française Anesthesie-Réanimation (SFAR)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal dysfunction	Renal dysfunction (defined by KDIGO stage 1 or higher)	during the first 14 postoperative days
Primary	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
Primary	Cardiovascular complication	Cardiovascular complication (defined by the development of acute heart failure)	during the first 14 postoperative days
Primary	Infectious complication	Infectious complication (defined by the development of sepsis, severe sepsis or septic shock)	during the first 14 postoperative days
Primary	Surgical complication	Surgical complication (defined as the need for surgical reoperation)	during the first 14 postoperative days
Secondary	Total fluid volume	Total fluid volume (0.9% saline and HES 130/0.4)	during the surgical period and the first 24 postoperative hours
Secondary	Volume of blood loss		during the surgical period and the first 24 postoperative hours
Secondary	Renal complications : oliguria	Postoperative complications	within 14 days
Secondary	Cardiovascular complications	Postoperative complications	within 14 days
Secondary	Respiratory complications	Postoperative complications	within 14 days
Secondary	SIRS score	Postoperative complications	within 14 days
Secondary	Infectious complications	Postoperative complications	within 14 days
Secondary	Surgical complications	Postoperative complications	within 14 days
Secondary	Severity organ failure assessment score from postoperative		Day-1 to Day-7
Secondary	Unexpected ICU admission (or readmission) following surgery		within 28 days
Secondary	All-cause mortality		28 days
Secondary	All-cause mortality		3 months
Secondary	Serum lactate		from Day-1 to Day-7
Secondary	C-reactive protein		from Day-1 to Day-7
Secondary	Plasma chloride		from Day-1 to Day-7
Secondary	number of units of packed red blood cells		during the surgical period and the first 24 postoperative hours