Pre-op Fluid Study

NCT ID: NCT05079269

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 550 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2025-11-30

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 bolus of a balanced crystalloid solution within 60 ± 15 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).

Conditions

Hypotension Drug-Induced; Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

The investigators will start a balanced crystalloid solution (in detail we will administer 500ml if the actual body weight is ≤90 kg: the investigators will administer 1000 ml if the actual body weight is \>90 kg:) within 60 +/- 15 minutes before induction of anesthesia in the pre-operative area or at the ward, as appropriate.

Group Type: EXPERIMENTAL

Crystalloid Solutions

Intervention Type: OTHER

As above

Control

Patients will receive the balanced crystalloid solution according to the current clinical standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Crystalloid Solutions

As above

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrea Kurz, Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz, Austria

Locations

Medical University Graz

Graz, Styria, Austria

Medical University Vienna

Vienna, Vienna, Austria

Countries

Austria

Other Identifiers

21

Identifier Type: -

Identifier Source: org_study_id