ColectomyNCT02509910
Implementation of a GDT Algorithm for Major Surgery Patients
An observational study of Colectomy and Pancreatectomy, run by Philipps University Marburg at 1 site in Germany.
Trial summary
This study examines the effect of an algorithm for GDT for patients undergoing major surgery under routine conditions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colectomy, Pancreatectomy, Fluid Therapy
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Jul 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing major abdominal surgery (Colorectal and pancreatic surgery)
Who may be able to join
- pancreatic surgery
- colorectal surgery
Who cannot join
- admission for revisional surgery
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: Implementation and Effects of Pulse-contour-automated SVV/CI Guided Goal Directed Fluid Therapy Algorithm for the Routine Management of Major Abdominal Surgery Patients
This study examines the effect of an algorithm for GDT for patients undergoing major surgery under routine conditions.
Read the detailed description
Goal directed fluid management in major abdominal surgery has been shown to reduce perioperative complications. The approach aims to optimize the intravascular fluid volume by use of minimally invasive devices which calculate flow-directed variables such as stroke volume (SV) and stroke volume variation (SVV). The investigators aim to show the feasibility of routinely implementing such hemodynamic monitoring during major abdominal surgery, and to evaluate its effects in terms of perioperative fluid management and postoperative outcomes.
- Conditions
- Colectomy, Pancreatectomy, Fluid Therapy
- Keywords
- Major abdominal surgery, Goal directed therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy | intraoperative standard fluid therapy for major abdominal surgery | |
| Goal directed therapy | intraoperative goal directed fluid therapy based on an angorithm lead by SVV/CI for major abdominal surgery patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in hospital
Measured: 90 days
Secondary outcomes (12)
intraoperative crystalloid volume
Measured: 1 day
intraoperative colloid volume
Measured: 1 day
Length of stay at ICU
Measured: 90 days
Total amount of complications per patient
Measured: 90 days
Insufficiance of bowel anastomosis
Measured: 90 days
Pneumonia
Measured: 90 days
ACS
Measured: 90 days
acute renal failure
Measured: 90 days
Sepsis
Measured: 90 days
Intraabd. Infection
Measured: 90 days
wound infection
Measured: 90 days
UTI
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2015 (estimated)
- Study startJul 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColectomyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 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, Phillips University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02509910
- Sponsor's protocol ID
- UKGMGDT
- Status last verified
- Jul 2015
- First submitted
- 22 Jul 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Effects of Pulse-contour-automated SVV/CI Guided Goal Directed Fluid Therapy Algorithm for the Routine Management of Major Abdominal Surgery Patients
- ClinicalTrials.gov ID
- NCT02509910
- Acronym / sponsor ID
- UKGMGDT
- Conditions
- Colectomy, Pancreatectomy, Fluid Therapy
- Keywords
- Major abdominal surgery, Goal directed therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 28 Jul 2015 (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.
This study examines the effect of an algorithm for GDT for patients undergoing major surgery under routine conditions.
Detailed description
Goal directed fluid management in major abdominal surgery has been shown to reduce perioperative complications. The approach aims to optimize the intravascular fluid volume by use of minimally invasive devices which calculate flow-directed variables such as stroke volume (SV) and stroke volume variation (SVV). The investigators aim to show the feasibility of routinely implementing such hemodynamic monitoring during major abdominal surgery, and to evaluate its effects in terms of perioperative fluid management and postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy | – | –intraoperative standard fluid therapy for major abdominal surgery |
| Goal directed therapy | – | –intraoperative goal directed fluid therapy based on an angorithm lead by SVV/CI for major abdominal surgery patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing major abdominal surgery (Colorectal and pancreatic surgery)
Key inclusion criteria (2 listed)
- pancreatic surgery
- colorectal surgery
Key exclusion criteria (1 listed)
- admission for revisional surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay in hospital
Time frame: 90 days
12 secondary outcomes
intraoperative crystalloid volume
Time frame: 1 day
intraoperative colloid volume
Time frame: 1 day
Length of stay at ICU
Time frame: 90 days
Total amount of complications per patient
Time frame: 90 days
Insufficiance of bowel anastomosis
Time frame: 90 days
Pneumonia
Time frame: 90 days
ACS
Time frame: 90 days
acute renal failure
Time frame: 90 days
Sepsis
Time frame: 90 days
Intraabd. Infection
Time frame: 90 days
wound infection
Time frame: 90 days
UTI
Time frame: 90 days
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 28 Jul 2015.
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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.
Thomas Kratz, MD principal investigator
Phillips University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colectomy and Pancreatectomy, 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 2 inclusion and 1 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 28 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. 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?
Length of stay in hospital (time frame: 90 days). 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 28 Jul 2015.