Hemostasis Evolution During Fluid Loading in Abdominal Surgery. Effects of Fluid Choice: Saline Versus Hydroxyethyl Starch (HAEMO Study)

Postoperative Morbidity Clinical Trial

— HAEMO  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420261
• Other study ID #: CHU-346
• Secondary ID: 2014-005578-84
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2017
• Est. completion date: July 30, 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.

Further investigation include the analysis of hemostasis modifications according to the fluid group during the first 7 days 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 30, 2018
• Est. primary completion date: July 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • - 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

• Included in Clermont-Ferrand and Montpellier centers

Exclusion Criteria:

• • - 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% hydroxyethyl 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

• Hemostasis Change
• Postoperative Morbidity
• Postoperative Mortality

Intervention

Biological:
• 0.9% saline
Fluid administration
• HES 130/0.4
Fluid administration

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (3)

Puéchal X, DeBandt M, Berthelot JM, Breban M, Dubost JJ, Fain O, Kahn JE, Lequen L, Longy-Boursier M, Perdriger A, Schaeverbeke T, Toussirot E, Sibilia J; Club Rhumatismes Et Inflammation. Tocilizumab in refractory adult Still's disease. Arthritis Care Res (Hoboken). 2011 Jan;63(1):155-9. doi: 10.1002/acr.20319. — View Citation

Soubrier M, Mathieu S, Payet S, Dubost JJ, Ristori JM. Elderly-onset rheumatoid arthritis. Joint Bone Spine. 2010 Jul;77(4):290-6. doi: 10.1016/j.jbspin.2010.04.004. Epub 2010 May 31. Review. — View Citation

Tournadre A, Dubost JJ, Soubrier M. Treatment of inflammatory muscle disease in adults. Joint Bone Spine. 2010 Oct;77(5):390-4. doi: 10.1016/j.jbspin.2010.04.007. Epub 2010 Jun 2. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prothombin Time	Evaluation of hemostasis parameters	at day 1
Primary	Activated Cephalin TimeF	Evaluation of hemostasis parameters	at day 1
Primary	Fibrinogen level and activity	Evaluation of hemostasis parameters	at day 1
Primary	Von Willebrand factor	Evaluation of hemostasis parameters	at day 1
Primary	Coagulation cascade	Evaluation of hemostasis parameters	at day 1
Primary	Thrombin Generation test	Evaluation of hemostasis parameters	at day 1
Primary	Fibrin Clot Permeability Test	Evaluation of hemostasis parameters	at day 1