Right Ventricular Impaired FunctionPhase 3SUCCESSNCT02782520
Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
A Phase 3 study testing Ringer Lactate (10ml/kg) fluid expansion and Hypertonic saline (3ml/kg) fluid expansion in people with Right Ventricular Impaired Function and Hypovolemia, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Impaired Function, Hypovolemia
- What is being tested?
- Ringer Lactate (10ml/kg) fluid expansion and Hypertonic saline (3ml/kg) fluid expansion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2016to Oct 2017
- Phase
- Phase 3
- 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
- Elective valvular or coronary surgery
- Under cardiopulmonary bypass
- Patient requiring Swan Ganz catheter monitoring
- Patient in sinus rhythm
- Patient requiring post-operative volemic expansion
- Echographic criteria of hypovolemia, without hypervolemia
Who cannot join
- Pulmonary hypertension (SPAP > 60mmHg)
- No pre-operative sinus rhythm
- Emergency surgery
- Age < 18 years
- Chronic renal failure treated with dialysis
- Severe hypernatremia
Trial locations and contacts
1 site in 1 country.
France1 site
Reanimation Cardiovasculaire Et Thoracique
La Tronche, Grenoble, 38043
About this study
This study is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.
Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.
Read more
Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).
Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.
- Conditions
- Right Ventricular Impaired Function, Hypovolemia
- Being tested
- Ringer Lactate (10ml/kg) fluid expansion, Hypertonic saline (3ml/kg) fluid expansion
- Keywords
- Cardiopulmonary bypass, Swan Ganz, Fluid expansion, hypertonic saline solution
- Medical subject headings
- Hypovolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ringer Lactate (10ml/kg) fluid expansionDrug
Hypertonic saline (3ml/kg) fluid expansionDrug
| Study group | Role | What they receive |
|---|---|---|
| Ringer Lactate | Active comparator | Ringer Lactate group Receives: Drug: Ringer Lactate (10ml/kg) fluid expansion |
| Hypertonic saline | Experimental | Hypertonic saline group Receives: Drug: Hypertonic saline (3ml/kg) fluid expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular ejection fraction change measured by Swan Ganz catheter.
Measured: after 30 minutes perfusion ( fluid expansion)
Secondary outcomes (12)
Left ventricular contractility
Measured: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Systolic volume change
Measured: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Cardiac output evolution.
Measured: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Tricuspid annular plane systolic excursion assessment
Measured: One hour before and after perfusion
Continuous cardiac output
Measured: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Blood volume efficiency
Blood volume efficiency included : Right systolic and diastolic ventricular volumes, measured by swan ganz catheter, central veinous pressure
Measured: One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion
Plasmatic volume monitoring
Plasmatic volume augmentation assessed by hemoglobin decrease
Measured: One hour before and , 1, 6 and 18 hours after perfusion
Natremia level
Measured: at 1, 6 and 18 hours after perfusion
Veinous oxygen saturation
Measured: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Mean arterial pressure assessment.
Measured: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Lactatemia level
Measured: at 1, 6 and 18 hours after perfusion
Acid base balance assessment.
Measured: at 1, 6 and 18 hours after perfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startAug 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Right Ventricular Impaired FunctionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782520
- Sponsor's protocol ID
- 38RC15.214
- Acronym
- SUCCESS
- Status last verified
- Nov 2017
- First submitted
- 29 Apr 2016
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1177/096721090000800101.
PubMed 10661697Gavazzi A, Berzuini C, Campana C, Inserra C, Ponzetta M, Sebastiani R, Ghio S, Recusani F. Value of right ventricular ejection fraction in predicting short-term prognosis of patients with severe chronic heart failure. J Heart Lung Transplant. 1997 Jul;16(7):774-85.
PubMed 9257260Christakis GT, Fremes SE, Weisel RD, Ivanov J, Madonik MM, Seawright SJ, McLaughlin PR. Right ventricular dysfunction following cold potassium cardioplegia. J Thorac Cardiovasc Surg. 1985 Aug;90(2):243-50.
PubMed 3875003Durand M, Chavanon O, Tessier Y, Casez M, Gardellin M, Blin D, Girardet P. Right ventricular function after coronary surgery with or without bypass. J Card Surg. 2006 Jan-Feb;21(1):11-6. doi: 10.1111/j.1540-8191.2006.00161.x.
PubMed 16426341Mouren S, Delayance S, Mion G, Souktani R, Fellahi JL, Arthaud M, Baron JF, Viars P. Mechanisms of increased myocardial contractility with hypertonic saline solutions in isolated blood-perfused rabbit hearts. Anesth Analg. 1995 Oct;81(4):777-82. doi: 10.1097/00000539-199510000-00021.
PubMed 7574010Ueti OM, Camargo EE, Ueti Ade A, de Lima-Filho EC, Nogueira EA. Assessment of right ventricular function with Doppler echocardiographic indices derived from tricuspid annular motion: comparison with radionuclide angiography. Heart. 2002 Sep;88(3):244-8. doi: 10.1136/heart.88.3.244.
PubMed 12181215Hammarstrom E, Wranne B, Pinto FJ, Puryear J, Popp RL. Tricuspid annular motion. J Am Soc Echocardiogr. 1991 Mar-Apr;4(2):131-9. doi: 10.1016/s0894-7317(14)80524-5.
PubMed 2036225Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22. No abstract available.
PubMed 22197117Scolletta S, Bodson L, Donadello K, Taccone FS, Devigili A, Vincent JL, De Backer D. Assessment of left ventricular function by pulse wave analysis in critically ill patients. Intensive Care Med. 2013 Jun;39(6):1025-33. doi: 10.1007/s00134-013-2861-8. Epub 2013 Mar 9.
PubMed 23474659
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of an Hypertonic Solution With Ringer Lactate on Right Ventricular Function Following Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02782520
- Acronym / sponsor ID
- SUCCESS / 38RC15.214
- Conditions
- Right Ventricular Impaired Function, Hypovolemia
- Keywords
- Cardiopulmonary bypass, Swan Ganz, Fluid expansion, hypertonic saline solution
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 25 May 2016 (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 is a phase III, randomized, controled, parallel groups, single blinded, clinical trial that aims at comparing the improvement of right ventricular function after administration of a hypertonic solution versus Ringer Lactate following cardiac surgery.
Adults patients admitted to Grenoble University Hospital for elective cardiac surgery under cardiopulmonary bypass, in sinus rhythm and with Swan Ganz monitoring will be included.
Patients needing fluid expansion in the first three hours after surgery will be randomized in two groups : one receiving Ringer Lactate (10 mL/kg), the other receiving hypertonic saline solution (3 mL/kg).
Right ventricular function measured with Swan Ganz catheter, 30 minutes after fluid expansion will be the primary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ringer Lactate | Active comparator | Drug: Ringer Lactate (10ml/kg) fluid expansionRinger Lactate group |
| Hypertonic saline | Experimental | Drug: Hypertonic saline (3ml/kg) fluid expansionHypertonic saline group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Elective valvular or coronary surgery
- Under cardiopulmonary bypass
- Patient requiring Swan Ganz catheter monitoring
- Patient in sinus rhythm
- Patient requiring post-operative volemic expansion
Key exclusion criteria (6 listed)
- Pulmonary hypertension (SPAP > 60mmHg)
- No pre-operative sinus rhythm
- Emergency surgery
- Age < 18 years
- Chronic renal failure treated with dialysis
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 |
|---|---|---|
| Ringer Lactate (10ml/kg) fluid expansion | Drug | Ringer Lactate |
| Hypertonic saline (3ml/kg) fluid expansion | Drug | Hypertonic saline |
Primary outcome
Right ventricular ejection fraction change measured by Swan Ganz catheter.
Time frame: after 30 minutes perfusion ( fluid expansion)
12 secondary outcomes
Left ventricular contractility
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Systolic volume change
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Cardiac output evolution.
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Tricuspid annular plane systolic excursion assessment
Time frame: One hour before and after perfusion
Continuous cardiac output
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Blood volume efficiency
Time frame: One hour before and 30, 60 minutes and 3, 6 and 18 hours after perfusion
Plasmatic volume monitoring
Time frame: One hour before and , 1, 6 and 18 hours after perfusion
Natremia level
Time frame: at 1, 6 and 18 hours after perfusion
Veinous oxygen saturation
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Mean arterial pressure assessment.
Time frame: at 30, 60 minutes and 3, 6 and 18 hours after perfusion
Lactatemia level
Time frame: at 1, 6 and 18 hours after perfusion
Acid base balance assessment.
Time frame: at 1, 6 and 18 hours after perfusion
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 30 Apr 2018.
- Background: PubMed 10661697Kaul TK, Fields BL. Postoperative acute refractory right ventricular failure: incidence, pathogenesis, management and prognosis. Cardiovasc Surg. 2000 Jan;8(1):1-9. doi: 10.1177/096721090000800101.
- Background: PubMed 9257260Gavazzi A, Berzuini C, Campana C, Inserra C, Ponzetta M, Sebastiani R, Ghio S, Recusani F. Value of right ventricular ejection fraction in predicting short-term prognosis of patients with severe chronic heart failure. J Heart Lung Transplant. 1997 Jul;16(7):774-85.
- Background: PubMed 3875003Christakis GT, Fremes SE, Weisel RD, Ivanov J, Madonik MM, Seawright SJ, McLaughlin PR. Right ventricular dysfunction following cold potassium cardioplegia. J Thorac Cardiovasc Surg. 1985 Aug;90(2):243-50.
- Background: PubMed 16426341Durand M, Chavanon O, Tessier Y, Casez M, Gardellin M, Blin D, Girardet P. Right ventricular function after coronary surgery with or without bypass. J Card Surg. 2006 Jan-Feb;21(1):11-6. doi: 10.1111/j.1540-8191.2006.00161.x.
- Background: PubMed 7574010Mouren S, Delayance S, Mion G, Souktani R, Fellahi JL, Arthaud M, Baron JF, Viars P. Mechanisms of increased myocardial contractility with hypertonic saline solutions in isolated blood-perfused rabbit hearts. Anesth Analg. 1995 Oct;81(4):777-82. doi: 10.1097/00000539-199510000-00021.
- Background: PubMed 12181215Ueti OM, Camargo EE, Ueti Ade A, de Lima-Filho EC, Nogueira EA. Assessment of right ventricular function with Doppler echocardiographic indices derived from tricuspid annular motion: comparison with radionuclide angiography. Heart. 2002 Sep;88(3):244-8. doi: 10.1136/heart.88.3.244.
- Background: PubMed 2036225Hammarstrom E, Wranne B, Pinto FJ, Puryear J, Popp RL. Tricuspid annular motion. J Am Soc Echocardiogr. 1991 Mar-Apr;4(2):131-9. doi: 10.1016/s0894-7317(14)80524-5.
- Background: PubMed 22197117Romano SM. Cardiac cycle efficiency: a new parameter able to fully evaluate the dynamic interplay of the cardiovascular system. Int J Cardiol. 2012 Mar 8;155(2):326-7. doi: 10.1016/j.ijcard.2011.12.008. Epub 2011 Dec 22. No abstract available.
- Background: PubMed 23474659Scolletta S, Bodson L, Donadello K, Taccone FS, Devigili A, Vincent JL, De Backer D. Assessment of left ventricular function by pulse wave analysis in critically ill patients. Intensive Care Med. 2013 Jun;39(6):1025-33. doi: 10.1007/s00134-013-2861-8. Epub 2013 Mar 9.
- 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 Phase 3 study testing Ringer Lactate (10ml/kg) fluid expansion and Hypertonic saline (3ml/kg) fluid expansion in people with Right Ventricular Impaired Function and Hypovolemia, run by University Hospital, Grenoble at 1 site in France.
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 6 inclusion and 6 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 30 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 France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Right ventricular ejection fraction change measured by Swan Ganz catheter. (time frame: after 30 minutes perfusion ( fluid expansion)). 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 NCT02782520, which also lists 9 linked publications.
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 Apr 2018.