Perioperative Fluid Management in Patients Receiving Major Abdominal Surgery - Effects of Normal Saline Versus an Acetate Buffered Balanced Infusion Solution on the Necessity of Catecholamines for Cardiocirculatory Support
NCT02414555 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2016-05-02
Summary
Background Intraoperative hypotension is a common problem that significantly contributes to perioperative mortality and morbidity. At the moment the "gold standard" for perioperative fluid management is the so called "goal-directed therapy" that features fluid resuscitation followed if necessary catecholamines if needed for perioperative cardiocirculatory support.
Worldwide the so called "physiological" sodium chlorid (0.9% NaCl) solution is the most often used infusate for perioperative fluid management. Despite its widespread use physiological saline has its major disadvantages such as the increased incidence of metabolic acidosis. Nevertheless catecholamines have their significant side effects as well (eg diminished renal perfusion, increased cardiovascular morbidity) and they therefore should be used with caution.
In a prior study by group members on patients undergoing renal transplantation receiving either physiological saline or an acetate-buffered infusate showed a 50% decrease in catecholamine necessity in the acetate-buffered infusate group. The investigators therefore would like to evaluate the effects of the perioperative fluid choice on the necessity of catecholamine use.
Aim
* Evaluation of the perioperative fluid choice on the necessity of catecholamines for cardiocirculatory support.
* Description of the relationship between perioperative fluid choice and minimal blood pressure as well as the time to catecholamine use and their dosage.
Methods The investigators plan a prospective randomized-controlled trial of all patients undergoing major abdominal surgery at the Vienna General Hospital and Medical University of Vienna. Fluid management and catecholamine use will be based on a oesophageal Doppler -based treatment scheme.
Conditions
- Critical Illness
Interventions
- DRUG
-
vasopressor
Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor
- DRUG
-
fluid bolus
- DEVICE
-
oesophagus doppler (CardioQ)
- DRUG
-
Normal Saline
- DEVICE
-
arterial cannulation
- DEVICE
-
intravenous peripheral line insertion (17 gauge)
for fluid bolus administration
- DRUG
-
Elo-Mel Isoton (balanced acetat-based infusate)
Sponsors & Collaborators
-
Medical University of Vienna
lead OTHER
Principal Investigators
-
Klaus Markstaller, MD · Clinic for General Anesthesia, Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-31
- Primary Completion
- 2016-03-31
- Completion
- 2016-03-31
Countries
- Austria
Study Locations
More Related Trials
-
Perioperative Fluid Management in Patients Receiving Cadaveric Renal Transplants
NCT01075750 ·Status: COMPLETED
-
Safety and Efficacy of Perioperative Volume Replacement with Volulyte 6% in Moderate-to-high Cardiovascular Risk Patients Having Major Abdominal Surgery
NCT06663254 ·Status: NOT_YET_RECRUITING ·Phase: PHASE4
-
Comparison Between Two Concentration of Hypertonic Saline in Intestinal Obstruction Surgery
NCT03741257 ·Status: UNKNOWN ·Phase: NA
-
Preventing Cardiovascular Collapse With Administration of Fluid Resuscitation During Induction and Intubation
NCT03787732 ·Status: COMPLETED ·Phase: PHASE4
-
Midodrine Versus Albumin for Prevention of Paracentesis Induced Circulatory Disturbance
NCT05240391 ·Status: COMPLETED ·Phase: PHASE3
-
PoCUS Guided Fluids to Prevent Post-induction Hypotension
NCT05424510 ·Status: COMPLETED ·Phase: NA
-
Efficacy, Safety of Hypertonic Lactate Soln. as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG Pats
NCT00529490 ·Status: COMPLETED ·Phase: PHASE3
-
Goal Directed Fluid Therapy
NCT00860704 ·Status: COMPLETED ·Phase: PHASE4
-
TOnicity of Perioperative Maintenance SoluTions
NCT03080831 ·Status: COMPLETED ·Phase: PHASE4
-
Impact of Fluid Management Within a Goal-directed Hemodynamic Protocol on Acid-base Balance in Elective Trauma Surgery
NCT01117519 ·Status: COMPLETED ·Phase: PHASE4
-
Hemodynamic Response to the End-expiratory Occlusion Test to Titrate Fluid Challenge in Operating Room.
NCT06627907 ·Status: NOT_YET_RECRUITING
-
Investigation of Fluid- and Electrolyte Balance in Post Cardiac-surgery Patients
NCT02914782 ·Status: COMPLETED
-
Perioperative Fluid Management: Goal-directed Versus Restrictive Strategy
NCT02625701 ·Status: COMPLETED ·Phase: PHASE3
-
Impact of Intraoperative Fluid Management on Electrolyte and Acid-base Variables
NCT03054922 ·Status: COMPLETED ·Phase: PHASE3
-
Can Vena Cava Ultrasound Guided Volume Repletion Prevent Spinal Induced Significant Hypotension in Elective Patients?
NCT02271477 ·Status: COMPLETED ·Phase: NA
-
Crystalloids or Colloids for Goal-directed Fluid Therapy With Closed-loop Assistance in Major Surgery
NCT02312999 ·Status: COMPLETED ·Phase: PHASE4
-
Fluid Management in the Post-Anesthetic Care Unit (PACU) at Sourasky Medical Center
NCT00995228 ·Status: UNKNOWN
-
Dose Responsive Study of Ringer's Lactate Solution in Prevention of Post-induction Hypotension
NCT05924230 ·Status: UNKNOWN ·Phase: NA
-
End-expiratory Occlusion Test and Lung Recruitment Maneuver to Assess Fluid responsiVeness In Surgical Patients
NCT03820440 ·Status: UNKNOWN ·Phase: NA
-
Effect of Goal-directed Crystalloid Versus Colloid Administration on Major Postoperative Morbidity
NCT01195883 ·Status: COMPLETED ·Phase: NA
-
Hemostasis Evolution During Fluid Loading in Abdominal Surgery. Effects of Fluid Choice: Saline Versus Hydroxyethyl Starch (HAEMO Study)
NCT03420261 ·Status: COMPLETED ·Phase: PHASE4
-
Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery
NCT00337805 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Fluid Management in the Post Anesthesia Care Unit
NCT03799250 ·Status: UNKNOWN ·Phase: PHASE4
-
The Effect on Fluid Balance After Cardiac Surgery After Use of Two Different Priming Protocols
NCT01511120 ·Status: COMPLETED ·Phase: PHASE2
-
Midodrine as Novel Treatment of Post-Cardiopulmonary Bypass Vasoplegic Syndrome
NCT04668859 ·Status: TERMINATED ·Phase: PHASE4