NCT03113435

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jun 2018Dec 2026

First Submitted

Initial submission to the registry

April 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

8.2 years

First QC Date

April 10, 2017

Last Update Submit

March 10, 2025

Conditions

Hemodynamic Instability

Keywords

CO2 gapoxygen consumptionStroke volume optimization

Outcome Measures

Primary Outcomes (1)

  • Perioperative fluid balance

    Perioperative fluid balance

    surgery

Secondary Outcomes (3)

  • Survival at 28 days

    28 days after surgery

  • Survival at hospital discharge

    1 day (Hospital discharge)

  • Post-operative complication

    1 day (Hospital discharge)

Study Arms (3)

Standard

NO INTERVENTION

In this group standard care will be provided to patients undergoing major abdominal surgery, regarding hemodynamic optimization

NICE group

ACTIVE COMPARATOR

In this arm patients will be treated according to stroke volume optimization described in NICE program

Other: Oxygen consumption optimization

Oxygen consumption group

EXPERIMENTAL

In this arm patients will receive hemodynamic optimization based on their oxygen consumption need

Other: Oxygen consumption optimization

Interventions

Oxygen consumption optimizationOTHER

hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio

NICE groupOxygen consumption group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Study Officials

  • Antonio M Dell'Anna, MD

    Fondazione Policlinico Universitario A. Gemelli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio M Dell'Anna, MD

CONTACT

+390630154490anthosdel@yahoo.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 10, 2017

First Posted

April 13, 2017

Study Start

June 1, 2018

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

Locations

IT(1)