Renal ImpairmentNCT01729364
Fluid Investigation Colloid vs Crystalloid Reg. Renal Hemodynamics and Function
A study testing crystalloid and colloid in people with Renal Impairment, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen demand. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Impairment
- What is being tested?
- crystalloid and colloid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to Dec 2014
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective fast track CABG patients, postoperative
Who cannot join
- hemodynamic instability
- preoperative renal impairment
- major postoperative bleeding
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Sahlgrenska University Hospital/Thoracic Intensive Care
Gothenburg, Västra Götaland County, 41345
About this study
Official title: Colloid vs Crystalloid Infusion Postoperative in CABG Patients Regarding Renal Hemodynamics and Function
Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen demand.
Read the detailed description
Due to blood loss and SIRS postoperative hypovolemia is a usual feature after CABG surgery. Substantial controversy persists regarding the best choice of fluid to be used for resuscitation in this setting regarding renal function and oxygen supply-demand matching. In our study we aim to investigate differences in functional renal parameters by dividing patients postoperatively in two groups, substituted either with crystalloid fluid, Ringer-Acetat, 20 ml/kg or colloid, HES 6% (130/0,4) 10 ml/kg under 20 minutes. Central and renal hemodynamics will be measured before (baseline) and after fluid administration by blood sampling and thermodilution in both pulmonary artery catheter and renal vein catheter. Measurement endpoints will mainly consist of central hemodynamics, renal blood flow, GFR and renal oxygen extraction rate which we aim to compare between groups.
- Conditions
- Renal Impairment
- Being tested
- crystalloid, colloid
- Keywords
- elective CABG, renal impairment, GFR, renal blood flow, colloid, crystalloid, thermodilution technique, oxygen supply demand
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crystalloidDrug
Also called Ringer Lactate, NaCl
colloidDrug
Also called Voluven, Venofundin, Tetraspan
| Study group | Role | What they receive |
|---|---|---|
| crystalloid | Experimental | crystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes Receives: Drug: crystalloid |
| colloid | Experimental | colloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes Receives: Drug: colloid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints
GFR measured by thermodilution and blood- and urine sampling baseline1 (0min), baseline2 (+30min), timepoint1 (+65min), tp2 (+85min), tp3 (+105min), tp4 (+125min)
Measured: 125min after baseline-measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startApr 2008
- Primary completionDec 2014
- Study completionDec 2014
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 Renal ImpairmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jenny Skytte Larsson, Sahlgrenska University Hospital
- Investigators
- Jenny Skytte Larsson, MD, Principal investigator, Sahlgrenska University HospitalSven-Erik Ricksten, Professor, Study chair, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729364
- Sponsor's protocol ID
- vätskestudien
- Status last verified
- May 2015
- First submitted
- 9 Nov 2012
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Skytte Larsson J, Bragadottir G, Krumbholz V, Redfors B, Sellgren J, Ricksten SE. Effects of acute plasma volume expansion on renal perfusion, filtration, and oxygenation after cardiac surgery: a randomized study on crystalloid vs colloid. Br J Anaesth. 2015 Nov;115(5):736-42. doi: 10.1093/bja/aev346.
PubMed 26475802
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colloid vs Crystalloid Infusion Postoperative in CABG Patients Regarding Renal Hemodynamics and Function
- ClinicalTrials.gov ID
- NCT01729364
- Acronym / sponsor ID
- vätskestudien
- Conditions
- Renal Impairment
- Keywords
- elective CABG, renal impairment, GFR, renal blood flow, colloid, crystalloid, thermodilution technique, oxygen supply demand
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 20 Nov 2012 (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.
Comparing the effects of crystalloid versus colloid fluid resuscitation in CABG patients postoperatively regarding renal blood flow, glomerular filtration rate and renal oxygen demand.
Detailed description
Due to blood loss and SIRS postoperative hypovolemia is a usual feature after CABG surgery. Substantial controversy persists regarding the best choice of fluid to be used for resuscitation in this setting regarding renal function and oxygen supply-demand matching. In our study we aim to investigate differences in functional renal parameters by dividing patients postoperatively in two groups, substituted either with crystalloid fluid, Ringer-Acetat, 20 ml/kg or colloid, HES 6% (130/0,4) 10 ml/kg under 20 minutes. Central and renal hemodynamics will be measured before (baseline) and after fluid administration by blood sampling and thermodilution in both pulmonary artery catheter and renal vein catheter. Measurement endpoints will mainly consist of central hemodynamics, renal blood flow, GFR and renal oxygen extraction rate which we aim to compare between groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crystalloid | Experimental | Drug: crystalloidcrystalloid fluid administration, Ringer-acetat 20ml/kg under 30 minutes |
| colloid | Experimental | Drug: colloidcolloidal fluids administration, HES 6% (130/0,4) 7ml/kg under 30 minutes |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective fast track CABG patients, postoperative
Key exclusion criteria (3 listed)
- hemodynamic instability
- preoperative renal impairment
- major postoperative bleeding
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 |
|---|---|---|
| crystalloidAlso: Ringer Lactate, NaCl | Drug | crystalloid |
| colloidAlso: Voluven, Venofundin, Tetraspan | Drug | colloid |
Primary outcome
Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints
Time frame: 125min after baseline-measures
GFR measured by thermodilution and blood- and urine sampling baseline1 (0min), baseline2 (+30min), timepoint1 (+65min), tp2 (+85min), tp3 (+105min), tp4 (+125min)
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 22 May 2015.
- Derived from this study: PubMed 26475802Skytte Larsson J, Bragadottir G, Krumbholz V, Redfors B, Sellgren J, Ricksten SE. Effects of acute plasma volume expansion on renal perfusion, filtration, and oxygenation after cardiac surgery: a randomized study on crystalloid vs colloid. Br J Anaesth. 2015 Nov;115(5):736-42. doi: 10.1093/bja/aev346.
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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.
Jenny Skytte Larsson, MD principal investigator
Sahlgrenska University Hospital
Sven-Erik Ricksten, Professor study chair
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing crystalloid and colloid in people with Renal Impairment, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 3 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 22 May 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 Sweden. 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?
Change from baseline and differences inbetween groups in glomerular filtration rate, measured at different timepoints (time frame: 125min after baseline-measures). 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 NCT01729364, 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 22 May 2015.