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

• Register: ClinicalTrials.gov
• Last refreshed on: 9 May 2016
• Main ID: NCT02414555
• Date of registration: 23/03/2015
• Prospective Registration: No
• Primary sponsor: Medical University of Vienna
• Public title: 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 KATECHOL
• Scientific title: 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, a Randomized Controlled Double-blind Trial
• Date of first enrolment: March 2015
• Target sample size: 60
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02414555
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Austria

Contacts

• Name: Klaus Markstaller, MD
• Affiliation: Clinic for General Anesthesia, Intensive Care and Pain Management, Medical University of Vienna, Vienna, Austria

Key inclusion & exclusion criteria

Inclusion Criteria:

- All patients scheduled for open elective major abdominal surgery and expected to last
a minimum of 2 hours will be included in the study.

(Major abdominal surgery includes all gynecological, urological and general surgical
operations requiring laparotomy)

Exclusion Criteria:

- Patients younger than 18 years of age

- Patients unable to give informed consent

- Pregnancy or breastfeeding

- Patients transferred form the intensive care unit to the operating theater

- Patients with an already established catecholamine therapy

- Emergency operation

- Chronic inflammatory diseases (chronic inflammatory rheumatoid diseases, chronic
inflammatory renal diseases, chronic inflammatory infectious diseases, chronic
inflammatory bowel diseases, chronic liver disease with signs of liver insufficiency)

- Severe cardiovascular disease (heart disease with an ejection fraction below 30%,
instable coronary syndromes, severe valvular disease)

- Any signs of infection or sepsis

- Any contraindication for oesophageal Doppler monitoring (oesophageal and aortic
pathology, planned oesophageal resection)

- Renal insufficiency with a glomerular filtration rate below 30ml/min

- Patients with additional epidural anesthesia are excluded from the study if epidural
anesthesia is planned to be used for analgesia intraoperatively



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Critical Illness

Intervention(s)

Drug: Elo-Mel Isoton (balanced acetat-based infusate)

Device: oesophagus doppler (CardioQ)

Drug: Normal Saline

Drug: vasopressor

Device: intravenous peripheral line insertion (17 gauge)

Device: arterial cannulation

Drug: fluid bolus

Primary Outcome(s)

catecholamine use to maintain target mean arterial pressure [Time Frame: hours of anesthesia (max 10 hours)]

Secondary Outcome(s)

difference in volume to maintain cardiovascular stability [Time Frame: hours of anesthesia (max 10 hours)]

unplanned ICU transfers [Time Frame: hours of anesthesia (max 10 hours)]

difference in dose of catecholamines to maintain cardiovascular stability [Time Frame: hours of anesthesia (max 10 hours)]

Secondary ID(s)

v1.104112014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors