Postoperative ComplicationsNCT01473446
Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients
A study testing Goal directed fluid therapy guided by LiDCOrapid in people with Postoperative Complications, run by Haukeland University Hospital at 3 sites in 2 countries.
Trial summary
Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients? The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- Goal directed fluid therapy guided by LiDCOrapid
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2012to Dec 2013
- 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
- Adult ASA class III \& IV (high risk) patients
- >18 years
- scheduled for gastrointestinal surgery involving laparotomy
- Both elective and emergency cases
Who cannot join
- Atrial fibrillation
- Mental impairment, unable to give informed consent
- Severe aortic or mitral stenosis
- Type of surgery: Liver surgery, transthoracic oesophagectomy
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Norway2 sites
Haukeland University Hospital
Bergen, 5021
Stavanger Universityhospital, Division for medical service, anesthesia and intensive care
Stavanger, 4011
Finland1 site
Oulu University Hospital, Department of Anesthesia and Intensive Care
Oulu, 90029
About this study
Official title: Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study
Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients?
The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the "traditional" fluids, ie the current regime.
- Conditions
- Postoperative Complications
- Being tested
- Goal directed fluid therapy guided by LiDCOrapid
- Keywords
- Goal directed fluid therapy, perioperative fluid therapy, LiDCOrapid, Postoperative outcome, Open abdominal surgery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal directed fluid therapy guided by LiDCOrapidProcedure or surgery
Standard monitoring. The patient is connected to the LiDCOrapid monitor via an arterial line placed in a.radialis. A bolus of 500 ml Ringer acetate is given before anesthesia. If the stroke volume (SV) increases more than 10%, repeat the procedure until the SV is not increasing. After that, induction of anesthesia.
Maintenance fluid is given as Ringer acetate 2ml/kg/t. Continuous monitoring of stroke volume variation (SVV). If SVV> 10%, give a fluid bolus 6ml/kg Ringer acetate. Repeat until SVV <10%. Bleeding is being replaced 1:1 with hydroxyethyl starch. SAG by bleeding >1000ml. By fall in blood pressure and SVV <10%, start vasoactive treatment with epinephrine. Postoperative is given Glucose 5% 80ml/h.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard monitoring. Initial optimization of fluid status is performed by pulse, BP and anaesthesiologist assessment with Ringer acetate. Followed by an infusion of 10ml/kg/t Ringer acetate. Urinary output and blood pressure is used as a surrogate parameter: the infusion rate is increased by a fall in blood pressure or urine output <0.5ml/kg/t. Bleeding replaced with HES 1:1, otherwise see table for fluid therapy page 9. Vasoactive agents (noradrenaline / phenylephrine) is given if the anesthesiologist considers this necessary. Postoperative give 1000ml Glucose 5%. HES or Ringer when low blood pressure, eventually noradrenaline as vasoactive agent. |
| Goal directed fluid therapy | Experimental | Not described Receives: Procedure: Goal directed fluid therapy guided by LiDCOrapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Measured: 5 days after surgery
Secondary outcomes (5)
Length of hospital stay
Measured: 3 month after surgery
Complications until discharge and readmission within 30 days
Measured: 3 month after surgery
Mortality within 30 days and 3-month after surgery
Measured: 3 month after surgery
Renal function
defined by RIFLE criteria
Measured: 5 days after surgery
Vasoactive agents need
Difference in the number of patients in need of vasoactive agents, during surgery and in the postoperative period.
Measured: 3 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2013
Why it stopped: High exclusion rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe 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
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ib Jammer, MD, Study chair, Helse Bergen HF, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01473446
- Sponsor's protocol ID
- 2011/947/REK Vest
- Status last verified
- Mar 2013
- First submitted
- 14 Nov 2011
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jammer I, Tuovila M, Ulvik A. Stroke volume variation to guide fluid therapy: is it suitable for high-risk surgical patients? A terminated randomized controlled trial. Perioper Med (Lond). 2015 Jul 22;4:6. doi: 10.1186/s13741-015-0016-x. eCollection 2015.
PubMed 26203353
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Versus Goal Directed Perioperative Fluid Therapy in High Risk Patients. A Randomized, Assessor-blinded Study
- ClinicalTrials.gov ID
- NCT01473446
- Acronym / sponsor ID
- 2011/947/REK Vest
- Conditions
- Postoperative Complications
- Keywords
- Goal directed fluid therapy, perioperative fluid therapy, LiDCOrapid, Postoperative outcome, Open abdominal surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High exclusion rate
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2013 (actual)
- First posted
- 17 Nov 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.
Is goal directed fluid therapy reducing postoperative complications in comparison to traditional fluid therapy for gastro surgical ASA III/IV patients?
The investigators compare two groups of patients: one group receives goal directed fluid therapy guided by LiDCOrapid stroke volume variation (SVV), the other gets the "traditional" fluids, ie the current regime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard monitoring. Initial optimization of fluid status is performed by pulse, BP and anaesthesiologist assessment with Ringer acetate. Followed by an infusion of 10ml/kg/t Ringer acetate. Urinary output and blood pressure is used as a surrogate parameter: the infusion rate is increased by a fall in blood pressure or urine output <0.5ml/kg/t. Bleeding replaced with HES 1:1, otherwise see table for fluid therapy page 9. Vasoactive agents (noradrenaline / phenylephrine) is given if the anesthesiologist considers this necessary. Postoperative give 1000ml Glucose 5%. HES or Ringer when low blood pressure, eventually noradrenaline as vasoactive agent. |
| Goal directed fluid therapy | Experimental | Procedure: Goal directed fluid therapy guided by LiDCOrapid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult ASA class III \& IV (high risk) patients
- >18 years
- scheduled for gastrointestinal surgery involving laparotomy
- Both elective and emergency cases
Key exclusion criteria (4 listed)
- Atrial fibrillation
- Mental impairment, unable to give informed consent
- Severe aortic or mitral stenosis
- Type of surgery: Liver surgery, transthoracic oesophagectomy
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 |
|---|---|---|
| Goal directed fluid therapy guided by LiDCOrapidStandard monitoring. The patient is connected to the LiDCOrapid monitor via an arterial line placed in a.radialis. A bolus of 500 ml Ringer acetate is given before anesthesia. If the stroke volume (SV) increases more than 10%, repeat the procedure until the SV is not increasing. After that, induction of anesthesia. Maintenance fluid is given as Ringer acetate 2ml/kg/t. Continuous monitoring of stroke volume variation (SVV). If SVV> 10%, give a fluid bolus 6ml/kg Ringer acetate. Repeat until SVV <10%. Bleeding is being replaced 1:1 with hydroxyethyl starch. SAG by bleeding >1000ml. By fall in blood pressure and SVV <10%, start vasoactive treatment with epinephrine. Postoperative is given Glucose 5% 80ml/h. | Procedure or surgery | Goal directed fluid therapy |
Primary outcome
Postoperative complications
Time frame: 5 days after surgery
5 secondary outcomes
Length of hospital stay
Time frame: 3 month after surgery
Complications until discharge and readmission within 30 days
Time frame: 3 month after surgery
Mortality within 30 days and 3-month after surgery
Time frame: 3 month after surgery
Renal function
Time frame: 5 days after surgery
Vasoactive agents need
Time frame: 3 month after surgery
Results and safety
The study was stopped early (reason given: High exclusion rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
- Derived from this study: PubMed 26203353Jammer I, Tuovila M, Ulvik A. Stroke volume variation to guide fluid therapy: is it suitable for high-risk surgical patients? A terminated randomized controlled trial. Perioper Med (Lond). 2015 Jul 22;4:6. doi: 10.1186/s13741-015-0016-x. eCollection 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.
Ib Jammer, MD study chair
Helse Bergen HF, Norway
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal directed fluid therapy guided by LiDCOrapid in people with Postoperative Complications, run by Haukeland University Hospital at 3 sites in 2 countries.
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 4 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: stopped early, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Norway, Finland. 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 stopped early (reason given: High exclusion rate). Results are not available in the source record.
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: 5 days after surgery). 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 NCT01473446, 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 30 Mar 2015.