Hemodynamic InstabilityNCT01811966
Preoperative Volume Substitution in Elective Surgery Patients
A study testing Volume in people with Hemodynamic Instability and Hypovolemia, run by Philipps University Marburg at 1 site in Germany.
Trial summary
Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia. The purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Instability, Hypovolemia, Anesthesia
- What is being tested?
- Volume
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- thyreoid, parathyroid or gallbladder surgery
- general anesthesia
Who cannot join
- coronary artery disease
- congestive heart disease (≥ New York Heart Association (NYHA) 2)
- insulin dependent diabetes mellitus
- renal insufficiency (creatinine > 2,0 mg/dl)
- cerebrovascular disease
- severe hypertension (≥ antihypertensive drugs)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Marburg, Department of Anesthesia
Marburg, D-35033
About this study
Official title: Preoperative Volume Substitution in Fasting Patients Undergoing Elective Surgery - Impact on Hemodynamic Stability During Anesthesia
Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia.
The purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities during introduction of anesthesia in elective surgery patients.
Read the detailed description
The preoperative fasting period often lasts longer than 2 hours as recommended by various national and international anesthetic guidelines. Thus, hypovolemia is more often then anticipated. In awake patients this condition is often masked. Introduction of anesthesia often leads to an unmasking of hypovolemia with a consecutive hemodynamic instability.
Aim of the study is to test the hypothesis that a preoperative volume substitution (8 ml/kg RingerAcetate Solution in 15 min. prior to introduction of anesthesia) reduces possible hemodynamic instabilities during initiation of anesthesia.
- Conditions
- Hemodynamic Instability, Hypovolemia, Anesthesia
- Being tested
- Volume, Control
- Keywords
- preoperative volume substitution, hypovolemia, preoperative fasting
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VolumeOther
Also called RingerAcetate Solution, cristalloide
ControlOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | preoperative none substitution of i.v. fluids. Receives: Other: Control |
| Volume | Active comparator | preoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia). Receives: Other: Volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemodynamic instability
Hemodynamic instability during induction of anesthesia (0-10 min), defined as at least one of the following:
- Systolic blood pressure < 80 mmHg or decrease of 20% in preexistent hypertension
- Mean blood pressure < 50 mmHg or decrease of 20% or > 20 mmHg in preexistent hypertension
- Bradycardia < 45/min or decrease of 20% in preexistent bradycardia < 60/min.
- Tachycardia > 120/min
- Cardiac index < 2.0 l/min/m²
Measured: at time of introduction of anesthesia
Secondary outcomes (4)
Stroke volume index > 35 ml/m2
Measured: at time of anesthesia
Stroke volume variation < 12 %
Measured: at time of anesthesia
Enddiastolic area (EDA) > 10 cm2
transthoracic echocardiographic parasternal short axis enddiastolic area
Measured: at time of anesthesia
inferior vana cava diameter (VCI) > 15 mm
transthoracic echocardiographic inferior vena cava diameter
Measured: at time of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Thomas Kratz, Philipps University Marburg
- Investigators
- Thomas Kratz, MD, Principal investigator, Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811966
- Sponsor's protocol ID
- UKGMVolume
- Other IDs
- UKGMVolume
- Status last verified
- Jul 2015
- First submitted
- 13 Mar 2013
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Volume Substitution in Fasting Patients Undergoing Elective Surgery - Impact on Hemodynamic Stability During Anesthesia
- ClinicalTrials.gov ID
- NCT01811966
- Acronym / sponsor ID
- UKGMVolume
- Conditions
- Hemodynamic Instability, Hypovolemia, Anesthesia
- Keywords
- preoperative volume substitution, hypovolemia, preoperative fasting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 15 Mar 2013 (estimated)
- 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.
Preoperative fasting can evoke a hypovolemia which may cause a hemodynamic instability during introduction of anesthesia.
The purpose of this study is to test the hypothesis that a defined preoperative volume substitution compared to standard procedure will result in a reduced incidence of hemodynamic instabilities during introduction of anesthesia in elective surgery patients.
Detailed description
The preoperative fasting period often lasts longer than 2 hours as recommended by various national and international anesthetic guidelines. Thus, hypovolemia is more often then anticipated. In awake patients this condition is often masked. Introduction of anesthesia often leads to an unmasking of hypovolemia with a consecutive hemodynamic instability.
Aim of the study is to test the hypothesis that a preoperative volume substitution (8 ml/kg RingerAcetate Solution in 15 min. prior to introduction of anesthesia) reduces possible hemodynamic instabilities during initiation of anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: Controlpreoperative none substitution of i.v. fluids. |
| Volume | Active comparator | Other: Volumepreoperative substitution of a defined amount of i.v. fluids (8 ml/kg RingerAcetate solution for 15 min prior to introduction of anesthesia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- thyreoid, parathyroid or gallbladder surgery
- general anesthesia
Key exclusion criteria (6 listed)
- coronary artery disease
- congestive heart disease (≥ New York Heart Association (NYHA) 2)
- insulin dependent diabetes mellitus
- renal insufficiency (creatinine > 2,0 mg/dl)
- cerebrovascular disease
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 |
|---|---|---|
| VolumeAlso: RingerAcetate Solution, cristalloide | Other | Volume |
| Control | Other | Control |
Primary outcome
hemodynamic instability
Time frame: at time of introduction of anesthesia
Hemodynamic instability during induction of anesthesia (0-10 min), defined as at least one of the following: * Systolic blood pressure < 80 mmHg or decrease of 20% in preexistent hypertension * Mean blood pressure < 50 mmHg or decrease of 20% or > 20 mmHg in preexistent hypertension * Bradycardia < 45/min or decrease of 20% in preexistent bradycardia < 60/min. * Tachycardia > 120/min * Cardiac index < 2.0 l/min/m²
4 secondary outcomes
Stroke volume index > 35 ml/m2
Time frame: at time of anesthesia
Stroke volume variation < 12 %
Time frame: at time of anesthesia
Enddiastolic area (EDA) > 10 cm2
Time frame: at time of anesthesia
inferior vana cava diameter (VCI) > 15 mm
Time frame: at time of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2015.
Related trials for Hemodynamic Instability
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruiting
Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
CPAP Ventilation, Sedation
Not yet recruitingObservational study
Development and Internal Validation of a Multimodal Prediction Score for Early Hemodynamic Deterioration in Adult Polytrauma Patients
Multiple Trauma, Polytrauma
RecruitingObservational study
Preoperative Neutrophil-to-Albumin Ratio and Post-Induction Hemodynamic Vulnerability in Major Oncologic Surgery
Hemodynamic Instability, Post-induction Hypotension (PIH)
RecruitingObservational study
Urine Output Response to Fluid and Diuretic Therapy in Cardiac ICU Patients Monitored With FIZE kUO®
AKI - Acute Kidney Injury, Cardiac Surgery
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.
Thomas Kratz, MD principal investigator
Department of Anesthesia and Intensive Care Medicine, University Hospital Marburg, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volume in people with Hemodynamic Instability and Hypovolemia, run by Philipps University Marburg at 1 site in Germany.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
hemodynamic instability (time frame: at time of introduction of anesthesia). 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 29 Jul 2015; AzTrials last refreshed its copy on 2 Nov 2026.