Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Oxygen consumption optimization.
- Who it may be relevant to
- Registry conditions: Hemodynamic Instability. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient Management During Major Abdominal Surgery: the Impact of a Hemodynamic Approach Oriented to Oxygen Consumption Optimization Compared to Standard Approach Targeting Preload-dependency and a Clinically-guided Strategy
Overview
This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.
Interventions
- Other Oxygen consumption optimization
hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio
Primary outcome measures
- Perioperative fluid balance [Time frame: surgery]
Secondary outcome measures (3)
- Survival at 28 days [Time frame: 28 days after surgery]
- Survival at hospital discharge [Time frame: 1 day (Hospital discharge)]
- Post-operative complication [Time frame: 1 day (Hospital discharge)]
Eligibility criteria
Inclusion criteria
- patients aged > 18 years
- acquisition of written informed consent
- Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours
Exclusion criteria
- Absolute contraindication to CVC placement
- pregnant women
- hepatic surgery
- laparoscopic surgery
- Major vascular surgery
- Dialysis treatment and kidney transplant surgery
- Severe heart failure (EF ≤ 35%)
- Emergency surgery
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico A. Gemelli IRCCS — Roma
Identifiers
NCT: NCT03113435 · 1305