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

NCT03420261 | Completed Phase 4

• 2 other identifiers: CHU-3462014-005578-84
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Morbidity; Postoperative Mortality; Hemostasis Change

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

Outcome Measures

Primary Outcomes (7)

• Prothombin Time

  Evaluation of hemostasis parameters

  at day 1

• Activated Cephalin TimeF

  Evaluation of hemostasis parameters

  at day 1

• Fibrinogen level and activity

  Evaluation of hemostasis parameters

  at day 1

• Von Willebrand factor

  Evaluation of hemostasis parameters

  at day 1

• Coagulation cascade

  Evaluation of hemostasis parameters

  at day 1

• Thrombin Generation test

  Evaluation of hemostasis parameters

  at day 1

• Fibrin Clot Permeability Test

  Evaluation of hemostasis parameters

  at day 1

Study Arms (2)

Crystalloid group

ACTIVE COMPARATOR

individualized goal-directed fluid optimization (cardiac preload) by 250 ml boluses of 0.9% saline (up to a maximum of 30 ml/kg)

Biological: 0.9% saline

Colloid group

EXPERIMENTAL

individualized goal-directed fluid optimization (cardiac preload) by 250 ml boluses of HES 130/0.4 (up to a maximum of 30 ml/kg, VOLUVEN ®, Fresenius Kabi)

Biological: HES 130/0.4

Interventions

0.9% saline BIOLOGICAL

Fluid administration

Crystalloid group

HES 130/0.4 BIOLOGICAL

Fluid administration

Colloid group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• - 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

You may not qualify if:

• - 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (3)

• Puechal 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.

  PMID: 20740616 BACKGROUND

• 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.

  PMID: 20627789 BACKGROUND

• 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.

  PMID: 20554241 BACKGROUND

MeSH Terms

Interventions

Saline Solution; Hydroxyethyl Starch Derivatives

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Starch; Dietary Carbohydrates; Carbohydrates; Glucans; Polysaccharides

Study Officials

• Thomas GODET

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2017
• First Posted: February 5, 2018
• Study Start: August 1, 2017
• Primary Completion: July 22, 2018
• Study Completion: July 30, 2018
• Last Updated: February 21, 2019

Record last verified: 2019-02

Locations

FR (1)