Clinical trial NCT05079269: Pre-op Fluid Study
Official title: Effect of Pre-operative Intravenous Crystalloids on Post-Induction Blood Pressure
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypotension Drug-Induced
Anesthesia
Keywords: Postinduction hypotension
Perioperative fluid management
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 550
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized intervention cohort study of two preoperative fluid management strategies
Primary purpose: TREATMENT

Brief summary: Theoretical framework:

Hypotension during surgery directly impacts patients' postoperative outcomes and complications. Decrease in blood pressure measurements secondary to anesthetic drugs is an expected scenario in most surgical cases. Moreover, hypovolemia secondary to fast pre-operative period may facilitate post-induction hypotension which can be compensated by fluid bolus pre-operatively.

Detailed description: Objectives:

The purpose of the study is to conduct a randomized intervention cohort study using pre-operative fluid therapy to assess its effect on blood pressure during the post-induction period. The investigators are testing the hypothesis that preoperative Crystalloid bolus decreases the risk of post-induction hypotension, specifically the time-weighted average (TWA) mean arterial pressure (MAP) under 65 mmHg during the first 20 minutes after anaesthetic induction or until surgical incision, whichever is first, compared to standard of care, which is minimal fluid administration in the pre-operative period.

Methods:

The investigators will conduct a randomized intervention cohort study using pre-operative fluid therapy to assess its effect on blood pressure during the post-induction period. The intervention group will receive a balanced crystalloid solution bolus within 20 to 40 minutes before induction of anaesthesia. The control group will be treated according to the current clinical standard of care. The investigators will compare the time-weighted average (TWA) mean arterial pressure (MAP) under 65 mmHg during the first 20 minutes after anaesthetic induction or until surgical incision (whichever comes first).

Eligibility criteria: Inclusion Criteria:

1. Scheduled for major non-cardiac surgery
2. Having general anaesthesia
3. Are designated ASA physical status ≥2 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life)
4. Subject to at least one of the following risk factors:

   1. Age ≥ 65 years
   2. History of peripheral arterial surgery
   3. History of coronary artery disease
   4. History of stroke or transient ischemic attack
   5. Serum creatinine \>175 µmol/L (\>2.0 mg/dl)
   6. Diabetes requiring medication
   7. Current smoking or 15 pack-year history of smoking tobacco
   8. Preoperative high-sensitivity troponin T \>14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay),75 19 ng/L (Siemens assay, \[Borges, unpublished\]), or 25% of the 99% percentile for other assays;
   9. B-type natriuretic protein (BNP) ≥ 80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) ≥ 200 ng/L.76,77
   10. History of atrial fibrillation
   11. Chronically taking at least one anti-hypertensive medication

Exclusion Criteria:

1. Are scheduled for carotid artery surgery
2. Are scheduled for intracranial surgery
3. Are scheduled for pheochromocytoma surgery
4. Require preoperative intravenous vasoactive medications
5. Active decompensated congestive heart failure (documented EF \< 30%)
6. Chronic Kidney Disease (eGFR\< 30 mL/min)
7. History of organ transplantation
8. Rectal surgical procedures
9. Patients receiving preoperative bowel preparation
10. Severe pulmonary edema

Primary outcomes:
measure: Post-induction MAP
timeFrame: 20 to 40 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)
Secondary outcomes:
measure: Vasopressors
timeFrame: 20 to 40 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)
measure: Cardiac Output (CO)
timeFrame: 20 to 40 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University Graz
state: Styria
city: Vienna
country: Austria
facility: Medical University Vienna
Study officials:
affiliation: Medical University of Graz, Austria
name: Andrea Kurz, Prof
role: PRINCIPAL_INVESTIGATOR
References: