Hypotension Drug-InducedNCT05079269
Pre-op Fluid Study
A study testing Crystalloid Solutions in people with Hypotension Drug-Induced and Anesthesia, run by Medical University of Graz at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypotension Drug-Induced, Anesthesia
- What is being tested?
- Crystalloid Solutions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 2 sitesAustria
- Study dates
- 1 Nov 2021to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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14 ng/L or troponin I equivalent, defined as ≥15 ng/L (Abbott assay),75 19 ng/L (Siemens assay, [Borges, unpublished]), or 25% of the 99% percentile for other assays;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
Who cannot join
- 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)
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- History of organ transplantation
- Rectal surgical procedures
- Patients receiving preoperative bowel preparation
- Severe pulmonary edema
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University Graz
Graz, Styria, 8036
Medical University Vienna
Vienna, State of Vienna
About this study
Official title: Effect of Pre-operative Intravenous Crystalloids on Post-Induction Blood Pressure
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.
Read the 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
- Being tested
- Crystalloid Solutions
- Keywords
- Postinduction hypotension, Perioperative fluid management
- Medical subject headings
- Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalloid SolutionsOther
As above
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Crystalloid Solutions |
| Control | No intervention | Patients will receive the balanced crystalloid solution according to the current clinical standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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)
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.
Measured: 60 +/- 15 minutes before induction of anesthesia until the first 20 minutes after anesthetic induction or until surgical incision (whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start1 Nov 2021
- Primary completion19 Jun 2024
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypotension Drug-InducedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized intervention cohort study of two preoperative fluid management strategies
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Kurz, Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05079269
- Sponsor's protocol ID
- 21
- Status last verified
- Apr 2025
- First submitted
- 1 Oct 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-operative Intravenous Crystalloids on Post-Induction Blood Pressure
- ClinicalTrials.gov ID
- NCT05079269
- Acronym / sponsor ID
- 21
- Conditions
- Hypotension Drug-Induced, Anesthesia
- Keywords
- Postinduction hypotension, Perioperative fluid management
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 19 Jun 2024 (actual)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- A randomized intervention cohort study of two preoperative fluid management strategies
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Crystalloid SolutionsThe 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. |
| Control | No intervention | –Patients will receive the balanced crystalloid solution according to the current clinical standard of care. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (10 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crystalloid SolutionsAs above | Other | Intervention |
Primary outcome
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.
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Kurz, Prof principal investigator
Medical University of Graz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crystalloid Solutions in people with Hypotension Drug-Induced and Anesthesia, run by Medical University of Graz at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.