Pre-op Fluid Study

NCT05079269 | Active Not Recruiting

• 1 other identifier: 21
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypotension Drug-Induced; Anesthesia

Keywords

Postinduction hypotension; Perioperative fluid management

Outcome Measures

Primary Outcomes (1)

• Post-induction MAP

  Post-induction hypotension is defined as TWA MAP under 65 mmHg during post-induction period. We will use non-invasive continuous arterial blood pressure monitoring as feasible. Anesthesia staff and nurses will be blinded, and standard of care will be provided. Data from the monitor will be recorded in the anesthesia record. We will be using standard intraoperative patient monitoring system. This system will measure 3 lead ECG (electrocardiogram), SpO2 (Arterial oxygen saturation), and number of respirations continuously. The primary outcome will be the TWA MAP under 65 mmHg during the post-induction period.

  60 +/- 15 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)

Secondary Outcomes (2)

• Vasopressors

  60 +/- 15 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)

• Cardiac Output (CO)

  60 +/- 15 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Crystalloid Solutions

Control

NO INTERVENTION

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

Interventions

Crystalloid Solutions OTHER

As above

Intervention

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for major non-cardiac surgery
• Having general anaesthesia
• Are designated ASA physical status ≥2 (ranging from mild systemic disease through severe systemic disease that is a constant threat to life)
• Subject to at least one of the following risk factors:
• Age ≥ 65 years
• History of peripheral arterial surgery
• History of coronary artery disease
• History of stroke or transient ischemic attack
• Serum creatinine \>175 µmol/L (\>2.0 mg/dl)
• Diabetes requiring medication
• Current smoking or 15 pack-year history of smoking tobacco
• 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;
• B-type natriuretic protein (BNP) ≥ 80 ng/L or N-terminal B-type natriuretic protein (NT-ProBNP) ≥ 200 ng/L.76,77
• History of atrial fibrillation
• Chronically taking at least one anti-hypertensive medication

You may not qualify if:

• Are scheduled for carotid artery surgery
• Are scheduled for intracranial surgery
• Are scheduled for pheochromocytoma surgery
• Require preoperative intravenous vasoactive medications
• Active decompensated congestive heart failure (documented EF \< 30%)
• Chronic Kidney Disease (eGFR\< 30 mL/min)
• History of organ transplantation
• Rectal surgical procedures
• Patients receiving preoperative bowel preparation
• Severe pulmonary edema

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (2)

Medical University Graz

Graz, Styria, 8036, Austria

Location

Medical University Vienna

Vienna, Vienna, Austria

Location

MeSH Terms

Conditions

Hypotension

Interventions

Crystalloid Solutions

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andrea Kurz, Prof

  Medical University of Graz, Austria

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized intervention cohort study of two preoperative fluid management strategies

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 15, 2021
• Study Start: November 1, 2021
• Primary Completion: June 19, 2024
• Study Completion: November 30, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will be transferred immediately after patient's enrolment and will be available until the end of the study for both sponsors (Medical University of Graz, Medical University of Vienna)
• Access Criteria: Access will only be provided to the Sponsor (Medical University of Graz and the Medical University of Vienna), the study investigators and the ethic commission (Ethic commission of the Medical University of Vienna).

Locations

AU (2)