To investigate whether personalized hemodynamic management targeting baseline cardiac index reduces the incidence of a composite outcome of acute kidney injury, acute myocardial injury, non-fatal cardiac arrest, severe infectious complications, and…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
grote buik operaties
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Collapsed composite endpoint (*any event versus none*) of acute kidney injury,
acute myocardial injury (including myocardial infarction), non-fatal cardiac
arrest, severe infectious complications, and death within 7 days after surgery.
Secondary outcome
* Incidence of the composite primary outcome within 3 days after surgery
* Incidences of each of the individual components of the primary outcome within
3 and 7 days after surgery
* Individual incidences of fever, respiratory infection, neurological
infection, urinary system infection, colitis or infection with Clostridium
difficile, endometritis, surgical site infection, deep incisional surgical site
infection, organ or space surgical site infection, unknown infection with
pathogenic organisms in tissue or fluid, and sepsis within 7 days after surgery
* Collapsed incidence and individual incidences of need for renal replacement
therapy, myocardial infarction, non-fatal cardiac arrest, and death within 30
days and 90 days after surgery
* Time-to-event endpoint with the event *transfer from intensive care unit to
normal ward* within 90 days after surgery
* Time-to-event endpoint with the event *hospital discharge* within 90 days
after surgery
* Incidence of unplanned hospital re-admission within 30 days after surgery
Background summary
Postoperative mortality within 30 days after surgery is around 2% in patients
having major noncardiac surgery in Europe and the USA. In fact, if the first 30
days after surgery were considered a disease, it would be the third leading
cause of death globally. Postoperative deaths are a consequence of
postoperative organ injury and complications - including acute myocardial
injury, acute kidney injury, and severe infectious complications. To avoid
postoperative deaths, it is thus crucial to reduce postoperative organ injury
and complications.
A single-center pilot trial suggests that using individualized cardiac index
targets during surgery may reduce postoperative organ injury and
complications compared to routine hemodynamic management. However, large robust
trials investigating the effect of personalized hemodynamic management
targeting preoperative baseline cardiac index on postoperative complications
are missing.
We, therefore, propose a multicenter randomized trial to test the hypothesis
that personalized hemodynamic management targeting preoperative baseline
cardiac index reduces the incidence of a composite outcome of acute kidney
injury, acute myocardial injury, non-fatal cardiac arrest, severe infectious
complications, and death within 7 days after surgery compared to routine
hemodynamic management in highrisk patients having major abdominal surgery.
Study objective
To investigate whether personalized hemodynamic management targeting baseline
cardiac index reduces the incidence of a composite outcome of acute kidney
injury, acute myocardial injury, non-fatal cardiac arrest, severe infectious
complications, and death within 7 days after surgery compared to routine
hemodynamic management in high-risk patients having major abdominal surgery.
Study design
This is an international multicenter randomized controlled blinded
interventional clinical trial.
Intervention
In patients assigned to personalized hemodynamic management, intraoperative
cardiac index will be maintained at least at the preoperative baseline cardiac
index. Patients assigned to personalized hemodynamic management will receive
balanced crystalloids at a baseline infusion rate of 6 mL kg-1 h-1 and
additional 500 mL fluid boluses (either colloid or crystalloid at the
discretion of the attending physician) and dobutamine according to the
treatment algorithm to maintain intraoperative cardiac index above the
individual preoperative baseline value measured just before surgery. Mean
arterial blood pressure will be maintained above 65 mmHg. The study
intervention will start at the beginning of surgery and will end at the end of
surgery.
Study burden and risks
Time-investment of approximatly 70-120 minutes in total, with very limited
risks (in rare occasions additional bloodsampling) and a benefit of less
expected risk on complications when in intervention group.
Martinistrasse 52
Hamburg 20246
DE
Martinistrasse 52
Hamburg 20246
DE
Listed location countries
Age
Inclusion criteria
Consenting patients >=45 years who are scheduled for elective major abdominal
surgery under general anesthesia that is expected to last >=90 minutes AND who
have >=1 of the following high-risk criteria:
* Exercise tolerance <4 metabolic equivalents as defined by the guidelines of
the American College of Cardiology/American Heart Association
* Renal impairment (serum creatinine >=1.3 mg dL-1 or estimated glomerular
filtration rate <90 mL min-1 (1.73 m2)-1 within the last 6 months)
* Coronary artery disease
* Chronic heart failure (New York Heart Association Functional Classification
>=II)
* Valvular heart disease (moderate or severe)
* History of stroke
* Peripheral arterial occlusive disease (any stage)
* Chronic obstructive pulmonary disease (any stage) or pulmonary fibrosis (any
stage)
* Diabetes mellitus requiring oral hypoglycemic agent or insulin
* Immunodeficiency due to a disease (e.g., HIV, leukemia, multiple myeloma) or
therapy (e.g., immunosuppressants, chemotherapy, radiation, steroids [above
Cushing threshold])
* Liver cirrhosis (any Child-Pugh class)
* Body mass index >=30 kg m-2
* History of smoking within two years of surgery
* Age >=65 years
* Expected anesthesia duration >=180 minutes
* B-type natriuretic peptide (BNP) >80 ng/L or N-terminal B-type natriuretic
peptide (NT-proBNP) >200 ng/L within the last 6 months
Exclusion criteria
* Emergency surgery
* Planned surgery: nephrectomy, liver or kidney transplantation surgery
* Status post transplantation of kidney, liver, heart, or lung
* Sepsis (according to current Sepsis-3 definition)
* American Society of Anesthesiologists physical status classification V or VI
* Pregnancy
* Impossibility to perform cardiac index monitoring using the Starling Fluid
Management System (Baxter, Deerfield, IL, USA)
* Current participation in another clinical trial of a treatment with a similar
biological mechanism or primary outcome measure
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84900.042.23 |
| Other | NTC05648279 |