Postoperative Morbidity Clinical Trial
Official title:
Hemostasis Evolution During Fluid Loading in Abdominal Surgery. Effects of Fluid Choice: Saline Versus Hydroxyethyl Starch (HAEMO Study, an Ancillary Study of FLASH Trial)
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.
Further investigation include the analysis of hemostasis modifications according to the fluid
group during the first 7 days 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.
Moreover conflicting results on hemostatic effects of HES have been reported. HES have been
associated with increased bleeding volume and transfusion requirements, especially in the ICU
setting in septic patients. Perioperative use of HES was not associated with such findings.
Biological effects of HES on hemostasis has barely been investigated and only by diluting
plasma of healthy donors with HES.
The proposed Haemo multicenter study will be conducted to assess if the use of HES or
crystalloid solutions during an individualized GDT contribute to biological hemostatic
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 and hemostasis.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05824260 -
Risk Factors for Postoperative Complications in Major Non-cardiac Surgery: Post-hoc Analysis of the OPHIQUE Multicentre Study
|
||
Completed |
NCT01145820 -
Fruit And Vegetables and OUtcomes After Removal of Impacted TEeth
|
N/A | |
Completed |
NCT03119532 -
Investigating Trends in Compliance With Quality Assurance Metrics
|
N/A | |
Recruiting |
NCT04969107 -
Abdominal or Transanal TME for Rectal Cancer Therapy
|
N/A | |
Completed |
NCT02502773 -
Fluid Loading in Abdominal Surgery: Saline Versus Hydroxyethyl Starch (FLASH Study)
|
Phase 3 | |
Completed |
NCT01515670 -
Length of Stay and Complications in High-risk Patients Receiving Fast-track Total Hip (THA) or Knee- Alloplasty (TKA)
|
||
Completed |
NCT03987789 -
Intraoperative Protective Mechanical Ventilation in Patients Requiring Emergency Abdominal Surgery
|
N/A |