Fluid Volume DisorderNCT01456702
Risk Stratification and Goal-directed Volume Therapy
A study testing risk stratification group in people with Fluid Volume Disorder, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
It is difficulte to evaluate risk patients and to find the ideal intraoperative volume management. It seems to be that ill patients benefit of a goal directed volume management. The aim of this study is to implement the guidelines on perioperative cardiovascular evaluation and care for non-cardiac sugery and to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fluid Volume Disorder
- What is being tested?
- risk stratification group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Mar 2016
- 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
- electiv orthopedic surgery with intermediate risk surgery
- signed informed consent
- >18 years
Who cannot join
- No consent for the study
- Age < 18 years
- Emergency surgery
- Pregnant women
- Jehovah's Witnesses
- Myocardial infarction in the last 4 weeks
- High-risk cardiac factors
- GOLD IV
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
Michael Sander, MD, +49-30-450 531 ext. 052, michael.sander@charite.de
Alexandra Lau, MD
About this study
Official title: Influence of Pre-operative Risk Stratefiction and Intraoperaitve Monitoring on Perioperative Volume Therapy and Postoperative Outcome
It is difficulte to evaluate risk patients and to find the ideal intraoperative volume management. It seems to be that ill patients benefit of a goal directed volume management. The aim of this study is to implement the guidelines on perioperative cardiovascular evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed protocoll for volume management.
Read the detailed description
It is difficult in the majority of cases to estimate the correct intra-operative mass of fluid therapy for each patient und needs a high degree of clinical experience. Among circumstances and problems of surgery (kind of surgery, length of time, bleeding, loss of liquid via wound) and kind of anesthesia, are also the concomitant diseases of patients relevant for the action of all anesthetists. These concomitant diseases correct to detect and to deduce corresponding consequences calls likewise for high clinical experience. Furthermore, the pre-operative fasting is an important fact.
Considering all these influencing factors the anesthetist tends rather to apply to much volume during surgery, followed by much more problems in PACU and / or intensive care unit.
However, how much volume is correct for which patient during which kind of surgery? How could the investigators estimate the really intra vessel volume deficit? Which available parameters are helpful, which monitoring is useful? These questions confront daily every anesthetist.
Monitoring of clinical "traditional" factors such as diuresis, blood pressure und heart rate are from experience to inexactly. Actually exist in the experts no uniform opinion about the kind and amount of fluid administration, which to apply, as well as the adequate monitoring. The central venous pressure, a commonly used parameter, is falling more and more behind.
Cardiac filling pressures correlate bad with filling volume and are unsuitable parameters for fluid therapy. It seems that dynamic parameters such as stroke volume (SV) and stroke volume variation (SVV) are better markers. SV and SVV could be measured by usual invasive blood pressure via LiDCO- or FloTrac-Monitoring.
In the study the investigators would show, that it is necessary to optimize processes already in the anesthetic ambulance, to evaluate patients with theirs concomitant diseases correctly followed by an improvement of intra-operative processes.
With the help of questionnaire is to be better structured and classified the cardiac risk of patients in accordance with the actually ACC / AHA guidelines (8). Depending surgery risk, the development of intra-operative monitoring happens standardized preoperatively (NIBP vs. IBP vs. SVV via FlowTrac or LiDCO). The intra-operative fluid regime will be performing in the group of NIBP and IBP on the basis of standard operating procedures (SOP) as well as in the group of SVV on the basis of a targeted-volume protocol.
There are a lot of surgeries with an increased fluid turnover and increased risk for cardiac complication. This demonstrated study limits the kind of surgeries on orthopedic operations with different requirement of intra-operative volume.
Hypothesis The daily challenge of each anesthetic is the correctly estimate of volume status during surgery. Multiple factors such as concomitant diseases, pre-operative fluid fasting, anesthesia as well as circumstances of surgery inclusive bleeding risk have an important influence followed by difficult peri-operative management.
The aim of this study is the improvement of peri-operative fluid management due to process optimisation already in the anesthetic ambulance included cardiac risk factors of patients followed by intra-operative fluid protocol. Primary outcome parameters are administered fluid volume (including blood transfusion), and secondary measured by amount of blood loss, postoperatively frequency of PONV, delir as well as PACU and ICU stay.
The investigator believes that the investigators could reduce the intra-operative fluid volume as well as blood loss due to these process optimization followed by increase patient satisfaction. Furthermore, the investigators could possibly reduce the PACU and ICU stay.
- Conditions
- Fluid Volume Disorder
- Being tested
- risk stratification group
- Keywords
- SVV, hemodynamic monitoring, goal-directed volume therapie
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risk stratification groupProcedure or surgery
Also called svv group
goal-directed volume therapy due to svv measurement or volume therapy via standard operated procedures in dependence of cardiac risk factores
| Study group | Role | What they receive |
|---|---|---|
| control arm | No intervention | volume therapy via standard operating procedure |
| intervention arm | Experimental | goal-directed volume therapy due to svv in dependence of preoperative risk stratefication Receives: Procedure: risk stratification group |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra- and postoperative volume
Measured: surgical time + treatment time until discharched to the ward or a maximum of 10 hours
Secondary outcomes (4)
treatment time in PACU, ICU, anesthetic recovery room
Measured: admission on PACU, ICU and anesthetic recovery room until a maximum of 10 hours
incidence of delirium and PONV
Measured: admission on ICU, PACU, anesthetic recovery room until discharge to the ward or a maximum of 10 hours
need of blood tranfusions
Measured: intra- and postoperative treatment time with a maximum of 10 hours postoperative
incidence of vasopressors
Measured: intra- and postoperative treatment time until a maximum of 10h postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2011 (estimated)
- Study startOct 2014
- Primary completionDec 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fluid Volume DisorderStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sander, Charite University, Berlin, Germany
- Investigators
- Michael Sander, MD, Principal investigator, Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456702
- Sponsor's protocol ID
- VoMo
- Status last verified
- Dec 2013
- First submitted
- 29 Sep 2011
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Pre-operative Risk Stratefiction and Intraoperaitve Monitoring on Perioperative Volume Therapy and Postoperative Outcome
- ClinicalTrials.gov ID
- NCT01456702
- Acronym / sponsor ID
- VoMo
- Conditions
- Fluid Volume Disorder
- Keywords
- SVV, hemodynamic monitoring, goal-directed volume therapie
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 21 Oct 2011 (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.
It is difficulte to evaluate risk patients and to find the ideal intraoperative volume management. It seems to be that ill patients benefit of a goal directed volume management. The aim of this study is to implement the guidelines on perioperative cardiovascular evaluation and care for non-cardiac sugery and to improve perioperative a goal-directed protocoll for volume management.
Detailed description
It is difficult in the majority of cases to estimate the correct intra-operative mass of fluid therapy for each patient und needs a high degree of clinical experience. Among circumstances and problems of surgery (kind of surgery, length of time, bleeding, loss of liquid via wound) and kind of anesthesia, are also the concomitant diseases of patients relevant for the action of all anesthetists. These concomitant diseases correct to detect and to deduce corresponding consequences calls likewise for high clinical experience. Furthermore, the pre-operative fasting is an important fact.
Considering all these influencing factors the anesthetist tends rather to apply to much volume during surgery, followed by much more problems in PACU and / or intensive care unit.
However, how much volume is correct for which patient during which kind of surgery? How could the investigators estimate the really intra vessel volume deficit? Which available parameters are helpful, which monitoring is useful? These questions confront daily every anesthetist.
Monitoring of clinical "traditional" factors such as diuresis, blood pressure und heart rate are from experience to inexactly. Actually exist in the experts no uniform opinion about the kind and amount of fluid administration, which to apply, as well as the adequate monitoring. The central venous pressure, a commonly used parameter, is falling more and more behind.
Cardiac filling pressures correlate bad with filling volume and are unsuitable parameters for fluid therapy. It seems that dynamic parameters such as stroke volume (SV) and stroke volume variation (SVV) are better markers. SV and SVV could be measured by usual invasive blood pressure via LiDCO- or FloTrac-Monitoring.
In the study the investigators would show, that it is necessary to optimize processes already in the anesthetic ambulance, to evaluate patients with theirs concomitant diseases correctly followed by an improvement of intra-operative processes.
With the help of questionnaire is to be better structured and classified the cardiac risk of patients in accordance with the actually ACC / AHA guidelines (8). Depending surgery risk, the development of intra-operative monitoring happens standardized preoperatively (NIBP vs. IBP vs. SVV via FlowTrac or LiDCO). The intra-operative fluid regime will be performing in the group of NIBP and IBP on the basis of standard operating procedures (SOP) as well as in the group of SVV on the basis of a targeted-volume protocol.
There are a lot of surgeries with an increased fluid turnover and increased risk for cardiac complication. This demonstrated study limits the kind of surgeries on orthopedic operations with different requirement of intra-operative volume.
Hypothesis The daily challenge of each anesthetic is the correctly estimate of volume status during surgery. Multiple factors such as concomitant diseases, pre-operative fluid fasting, anesthesia as well as circumstances of surgery inclusive bleeding risk have an important influence followed by difficult peri-operative management.
The aim of this study is the improvement of peri-operative fluid management due to process optimisation already in the anesthetic ambulance included cardiac risk factors of patients followed by intra-operative fluid protocol. Primary outcome parameters are administered fluid volume (including blood transfusion), and secondary measured by amount of blood loss, postoperatively frequency of PONV, delir as well as PACU and ICU stay.
The investigator believes that the investigators could reduce the intra-operative fluid volume as well as blood loss due to these process optimization followed by increase patient satisfaction. Furthermore, the investigators could possibly reduce the PACU and ICU stay.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control arm | No intervention | –volume therapy via standard operating procedure |
| intervention arm | Experimental | Procedure: risk stratification groupgoal-directed volume therapy due to svv in dependence of preoperative risk stratefication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- electiv orthopedic surgery with intermediate risk surgery
- signed informed consent
- >18 years
Key exclusion criteria (8 listed)
- No consent for the study
- Age < 18 years
- Emergency surgery
- Pregnant women
- Jehovah's Witnesses
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 |
|---|---|---|
| risk stratification groupAlso: svv groupgoal-directed volume therapy due to svv measurement or volume therapy via standard operated procedures in dependence of cardiac risk factores | Procedure or surgery | intervention arm |
Primary outcome
intra- and postoperative volume
Time frame: surgical time + treatment time until discharched to the ward or a maximum of 10 hours
4 secondary outcomes
treatment time in PACU, ICU, anesthetic recovery room
Time frame: admission on PACU, ICU and anesthetic recovery room until a maximum of 10 hours
incidence of delirium and PONV
Time frame: admission on ICU, PACU, anesthetic recovery room until discharge to the ward or a maximum of 10 hours
need of blood tranfusions
Time frame: intra- and postoperative treatment time with a maximum of 10 hours postoperative
incidence of vasopressors
Time frame: intra- and postoperative treatment time until a maximum of 10h postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
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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.
Michael Sander, MD principal investigator
Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing risk stratification group in people with Fluid Volume Disorder, run by Charite University, Berlin, Germany 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 8 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: status not confirmed, as of the sponsor's last update on 31 Dec 2013. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Sander, MD (+49-30-450531 ext. 052, michael.sander@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intra- and postoperative volume (time frame: surgical time + treatment time until discharched to the ward or a maximum of 10 hours). 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 31 Dec 2013.