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NCT Number: NCT05079269

Pre-op Fluid Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University Vienna, Vienna, State of Vienna, Austria

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Crystalloid Solutions

Other

As above

Primary outcomes

  1. Post-induction MAP

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

    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.

Secondary outcomes

  1. Vasopressors

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

    The major outcome for the vasopressor requirement will be a binary variable representing the use of vasopressors during the post-induction period. Additionally, we will compare the amount of vasopressors between the groups.

  2. Cardiac Output (CO)

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

    The major outcome for the non-invasively measured CO will be a continuous measurement throughout pre-induction, induction of anesthesia and post-induction as feasible.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study title

Effect of Pre-operative Intravenous Crystalloids on Post-Induction Blood Pressure

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Oct 15, 2021
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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