Reduction of Length of Hospitality Stay, Reduction of Perioperative ComplicationsNCT01401283
GDT by Cardiac Index Trending Via a Radial Arterial Line in General Surgery
A study testing measurement of cardiac output and pulse pressure variation in people with Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications
- What is being tested?
- measurement of cardiac output and pulse pressure variation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- major abdominal surgery
- duration of surgery > 2 hours
Who cannot join
- age < 18 years
- scheduled postoperative icu treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center, Prospective, Randomized Outcome Study Comparing Continuous Cardiac Index Trending Via a Radial Arterial Line Versus Standard Care in General Surgical Patients
This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients
Read the detailed description
This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.
- Being tested
- measurement of cardiac output and pulse pressure variation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of cardiac output and pulse pressure variationDevice
hemodynamic optimization according to cardiac index and pulse pressure variation
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation, measurement of cardiac output and pulse pressure variation, hemodynamic optimization according to cardiac index and pulse pressure variation Receives: Device: measurement of cardiac output and pulse pressure variation |
| Control group | No intervention | hemodynamic management according to institutional clinical standards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications
Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF)
Measured: Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days
Secondary outcomes (1)
Hospital Stay
length of stay in the postoperative care unit, length of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Reduction of Length of Hospitality Stay, Reduction of Perioperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Northern State Medical University, Szeged University, University of Kiel, University of Witten/Herdecke, University of Valencia
- Responsible party
- Sponsor
- Investigators
- Daniel A Reuter, MD, Principal investigator, Universitätsklinikum Hamburg-Eppendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401283
- Sponsor's protocol ID
- 797726
- Status last verified
- Jan 2016
- First submitted
- 8 Jul 2011
- Last updated
- 5 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
PubMed 24010849
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Prospective, Randomized Outcome Study Comparing Continuous Cardiac Index Trending Via a Radial Arterial Line Versus Standard Care in General Surgical Patients
- ClinicalTrials.gov ID
- NCT01401283
- Acronym / sponsor ID
- 797726
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Northern State Medical University, Szeged University, University of Kiel, University of Witten/Herdecke, University of Valencia
- Study start
- Jul 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 5 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients
Detailed description
This is a multi-Center, prospective, randomized Outcome Study comparing continuous cardiac index trending via a radial arterial line versus standard care in general surgical patients Clinical outcome of patients undergoing major abdominal surgery is explored in two different groups. In one group hemodynamic management is guided by the internal standard of the anesthesiological department. In the other group fluid management is goal directed by by continuous cardiac index trending via a radial arterial line and pulse pressure variation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Device: measurement of cardiac output and pulse pressure variationintraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation, measurement of cardiac output and pulse pressure variation, hemodynamic optimization according to cardiac index and pulse pressure variation |
| Control group | No intervention | –hemodynamic management according to institutional clinical standards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- major abdominal surgery
- duration of surgery > 2 hours
Key exclusion criteria (2 listed)
- age < 18 years
- scheduled postoperative icu treatment
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 |
|---|---|---|
| measurement of cardiac output and pulse pressure variationhemodynamic optimization according to cardiac index and pulse pressure variation | Device | Study group |
Primary outcome
Postoperative Complications
Time frame: Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days
Categories of postoperative complications: Infection (respiratory, abdominal, UTI, wound), Respiratory (prolonged need for ventilation), Cardiovascular (edema, arrythmia, hypotension, AMI, stroke), Abdominal (constipation), Renal (urine output <500ml/d, ARF)
1 secondary outcome
Hospital Stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 10 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24010849Salzwedel C, Puig J, Carstens A, Bein B, Molnar Z, Kiss K, Hussain A, Belda J, Kirov MY, Sakka SG, Reuter DA. Perioperative goal-directed hemodynamic therapy based on radial arterial pulse pressure variation and continuous cardiac index trending reduces postoperative complications after major abdominal surgery: a multi-center, prospective, randomized study. Crit Care. 2013 Sep 8;17(5):R191. doi: 10.1186/cc12885.
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.
Daniel A Reuter, MD principal investigator
Universitätsklinikum Hamburg-Eppendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of cardiac output and pulse pressure variation in people with Reduction of Length of Hospitality Stay, Reduction of Perioperative Complications, run by Universitätsklinikum Hamburg-Eppendorf 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 2 inclusion and 2 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 5 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 5 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Postoperative Complications (time frame: Participants will be followed from end of surgery for the duration of stay in the recovery room, for the duration of the complete hospital stay, an expected average of ten 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01401283, which also lists 1 linked publication.
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 5 Feb 2016.