Back to resultsPre-op Fluid Study
Primary Purpose
Hypotension Drug-Induced, Anesthesia
Status
Recruiting
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Crystalloid Solutions
Sponsored by
About this trial
This is an interventional treatment trial for Hypotension Drug-Induced focused on measuring Postinduction hypotension, Perioperative fluid management
Eligibility Criteria
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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay),75 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percentile for other assays;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
Sites / Locations
- Medical University GrazRecruiting
- Medical University ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
The investigators will start a balanced crystalloid solution (in detail we will administer 500ml if the actual body weight is ≤80 kg: the investigators will administer 1000 ml if the actual body weight is >80 kg:) within 20 to 40 minutes before induction of anesthesia in the pre-operative area or at the ward, as appropriate.
Patients will receive the balanced crystalloid solution according to the current clinical standard of care.
Outcomes
Primary Outcome Measures
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.
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 Outcome Measures
Vasopressors
The major outcome for the vasopressor requirement will be a binary variable representing the use of vasopressors during the post-induction period.
Cardiac Output (CO)
The major outcome for the non-invasively measured CO will be a continuous measurement throughout pre-induction, induction of anesthesia and post-induction.
Full Information
NCT ID
NCT05079269
First Posted
October 1, 2021
Last Updated
September 4, 2023
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT05079269
Brief Title
Pre-op Fluid Study
Official Title
Effect of Pre-operative Intravenous Crystalloids on Post-Induction Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension Drug-Induced, Anesthesia
Keywords
Postinduction hypotension, Perioperative fluid management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A randomized intervention cohort study of two preoperative fluid management strategies
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
550 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
The investigators will start a balanced crystalloid solution (in detail we will administer 500ml if the actual body weight is ≤80 kg: the investigators will administer 1000 ml if the actual body weight is >80 kg:) within 20 to 40 minutes before induction of anesthesia in the pre-operative area or at the ward, as appropriate.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will receive the balanced crystalloid solution according to the current clinical standard of care.
Intervention Type
Other
Intervention Name(s)
Crystalloid Solutions
Intervention Description
As above
Primary Outcome Measure Information:
Title
Post-induction MAP
Description
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.
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.
Time Frame
20 to 40 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)
Secondary Outcome Measure Information:
Title
Vasopressors
Description
The major outcome for the vasopressor requirement will be a binary variable representing the use of vasopressors during the post-induction period.
Time Frame
20 to 40 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)
Title
Cardiac Output (CO)
Description
The major outcome for the non-invasively measured CO will be a continuous measurement throughout pre-induction, induction of anesthesia and post-induction.
Time Frame
20 to 40 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Eichinger, MD, MSc
Phone
00436644197727
Email
michael.eichinger@medunigraz.at
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Eichinger, MD, MSc
Phone
004331638580515
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Kurz, Prof
Organizational Affiliation
Medical University of Graz, Austria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University Graz
City
Graz
State/Province
Styria
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Eichinger, MD, MSc
Phone
004331638580515
Email
michael.eichinger@medunigraz.at
Facility Name
Medical University Vienna
City
Vienna
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Reiterer, Dr
Email
christian.reiterer@meduniwien.ac.at
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
For electronic data management we will use the CLINCASE software (Quadratek, Berlin, Germany). Data storage and back up will be provided by IT Systems & Communications (ITSC) - IT4Science (Medical University of Vienna). Access to data is strictly controlled and 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).
All entries and changes in the CLINCASE software will be tracked.
IPD Sharing 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)
IPD Sharing 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).
Learn more about this trial
Pre-op Fluid Study
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