Vascular HypotensionNCT03213574
Impact of GDT in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients
A study testing Treatment Group in people with Vascular Hypotension and Hypovolemia, run by Loma Linda University at 1 site in United States.
Trial summary
Robot assisted urological procedures are often long surgical cases that can potentially result in complicated postoperative hospital course. The amount of intravenous (IV) fluids administered to patients during these operations fluctuates based on the length of the case, surgical blood loss, hemodynamic monitors, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Hypotension, Hypovolemia, Hypervolemia
- What is being tested?
- Treatment Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2017to Apr 2018
- 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
- Patients undergoing robot-assisted laparoscopic urological procedures in which the patient would have an arterial catheter placed as part of their routine inoperative anesthetic management
Who cannot join
- Age less than 18;
- current pregnancy;
- history of congestive heart failure, arrhythmias, coagulopathy, cerebral vascular disease , COPD, significant liver or renal impairment, required FloTrac per treating anesthesiologist;
- patient refusal to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Goal Directed Fluid Therapy in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients
Robot assisted urological procedures are often long surgical cases that can potentially result in complicated postoperative hospital course. The amount of intravenous (IV) fluids administered to patients during these operations fluctuates based on the length of the case, surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid status and analyze post-operative outcomes.
- Conditions
- Vascular Hypotension, Hypovolemia, Hypervolemia
- Being tested
- Control Group, Treatment Group
- Keywords
- Goal directed fluid therapy
- Medical subject headings
- Hypotension, Hypovolemia, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control GroupOther
Intraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol.
Treatment GroupOther
FloTrac arterial line data will be used to administer fluid bolus, based on study algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | The control group will be administered intraoperative fluids throughout his or her surgery per the discretion of the anesthesiologist as is typical for this type of case. They will use an arterial line but without a FloTrac and therefore will have no data regarding the SVV. Receives: Other: Control Group |
| Treatment Group | Experimental | The treatment group will receive a FloTrac arterial line that will allow the anesthesiologist to administer intraoperative fluids based on the study algorithm. Receives: Other: Treatment Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative ileus
Time postoperatively to first bowel movement
Measured: Up to 3 weeks postoperatively
Secondary outcomes (4)
Acute kidney injury
Will be measured using the KDIGO criteria (UOP and Cr)
Measured: Up to 3 weeks postoperatively
Respiratory compromise
Patients that require oxygen or invasive/non-invasive mechanical ventilation postoperatively
Measured: Up to 3 weeks postoperatively
Need for diuresis
Use of a diuretic medication (ex. lasix, metolazone)
Measured: Up to 3 weeks postoperatively
Hospital length of stay
Duration of stay in the hospital
Measured: Up to 4 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study startDec 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: Principal Investigator is making changes to the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular HypotensionStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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
- Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronak Raval, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03213574
- Sponsor's protocol ID
- 5170073
- Status last verified
- Apr 2018
- First submitted
- 6 Feb 2017
- Last updated
- 5 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Goal Directed Fluid Therapy in Robot-assisted Laparoscopic Urological Surgery for Low to Moderate Risk Patients
- ClinicalTrials.gov ID
- NCT03213574
- Acronym / sponsor ID
- 5170073
- Conditions
- Vascular Hypotension, Hypovolemia, Hypervolemia
- Keywords
- Goal directed fluid therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Principal Investigator is making changes to the protocol.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 11 Jul 2017 (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.
Robot assisted urological procedures are often long surgical cases that can potentially result in complicated postoperative hospital course. The amount of intravenous (IV) fluids administered to patients during these operations fluctuates based on the length of the case, surgical blood loss, hemodynamic monitors, and the discretion of the anesthesiologist. The goal of intraoperative fluid therapy is to maintain optimal tissue perfusion without causing fluid overload. We plan to use a goal directed fluid therapy protocol to optimize fluid status and analyze post-operative outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Other: Control GroupThe control group will be administered intraoperative fluids throughout his or her surgery per the discretion of the anesthesiologist as is typical for this type of case. They will use an arterial line but without a FloTrac and therefore will have no data regarding the SVV. |
| Treatment Group | Experimental | Other: Treatment GroupThe treatment group will receive a FloTrac arterial line that will allow the anesthesiologist to administer intraoperative fluids based on the study algorithm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing robot-assisted laparoscopic urological procedures in which the patient would have an arterial catheter placed as part of their routine inoperative anesthetic management
Key exclusion criteria (4 listed)
- Age less than 18;
- current pregnancy;
- history of congestive heart failure, arrhythmias, coagulopathy, cerebral vascular disease , COPD, significant liver or renal impairment, required FloTrac per treating anesthesiologist;
- patient refusal to consent
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 |
|---|---|---|
| Control GroupIntraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol. | Other | Control Group |
| Treatment GroupFloTrac arterial line data will be used to administer fluid bolus, based on study algorithm. | Other | Treatment Group |
Primary outcome
Postoperative ileus
Time frame: Up to 3 weeks postoperatively
Time postoperatively to first bowel movement
4 secondary outcomes
Acute kidney injury
Time frame: Up to 3 weeks postoperatively
Respiratory compromise
Time frame: Up to 3 weeks postoperatively
Need for diuresis
Time frame: Up to 3 weeks postoperatively
Hospital length of stay
Time frame: Up to 4 weeks postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Group in people with Vascular Hypotension and Hypovolemia, run by Loma Linda University at 1 site in United States.
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 1 inclusion and 4 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: withdrawn, as of the sponsor's last update on 5 Apr 2018. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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 ileus (time frame: Up to 3 weeks postoperatively). 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 5 Apr 2018.