Coronary Artery DiseasePhase 2ESHHSNCT01675453
The Efficacy and Safety of Hypertonic Saline in Cardiac Surgery Patients.
A Phase 2 study testing 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 and 0.9% NaCl in people with Coronary Artery Disease and Edema, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial summary
The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Coronary Artery Disease, Edema
- What is being tested?
- 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 and 0.9% NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteRussia
- Study dates
- Jan 2012to Sep 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass
Who cannot join
- age >70 years
- body mass index <18 and >35 kg/m2
- left ventricular ejection fraction <40%
- myocardial infarction <6 months before surgery
- stroke or transient ischemic attack <12 months before surgery
- diabetes mellitus
Show all 9Show fewer
- glomerular filtration rate <90 mL/min
- emergency surgery
- hematocrit <30%.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Novosibirsk Research Institute of Pathology of Circulation
Novosibirsk, Novosibirsk Territory, 630055
About this study
Official title: The Efficacy and Safety of 7.2% NaCl Plus 6% Hydroxyethyl 200/0.5 in Patients Scheduled for First-time Coronary Artery Bypass Grafting With Cardiopulmonary Bypass.
The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes.
Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment.
The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.
- Conditions
- Coronary Artery Disease, Edema
- Being tested
- 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5, 0.9% NaCl
- Keywords
- Organ dysfunction, Hypertonic solution, Extravascular water, Cardiopulmonary Bypass
- Medical subject headings
- Coronary Artery Disease, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7.2% NaCl plus 6% hydroxyethyl starch 200/0.5Drug
Also called HyperHAES
0.9% NaClDrug
Also called Saline
| Study group | Role | What they receive |
|---|---|---|
| 7.2% NaCl /hydroxyethyl starch 200/0.5 | Active comparator | On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) Receives: Drug: 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 |
| 0.9% NaCl | Placebo comparator | On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) Receives: Drug: 0.9% NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extravascular Lung Water Index
Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight".
Measured: baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1
Secondary outcomes (15)
Pulmonary Oxygenation
Index of arterial oxygenation efficiency (PaO2/FiO2), alveolar-arterial oxygen tension difference (AaDO2) will be used to assess this outcome measure.
Measured: 24 hours
Oxygen Delivery
Oxygen delivery index (DO2I) will be used to assess this outcome measure.
Measured: 24 hours
Cardiac Index
Measured: 24 hours
Fluid Balance
Net fluid balance at the end of surgery equals the sum of all infusions minus the urine output. Net fluid balance at postoperative day 1 equals the sum of all infusions minus the urine output and blood loss.
Measured: 24 hours
Inflammation Response
Serum levels of Interleukin 6 (IL-6) and Interleukin 10 (IL-10) will be used to assess this outcome measure.
Measured: 24 hours
Endothelial Integrity
Serum levels of intercellular adhesion molecule-1 (ICAM-1), E-selectin will be used to assess this outcome measure.
Measured: 24 hours
Plasma Na
Measured: 24 hours
Plasma Osmolarity
Measured: 24 hours
Rate of Acute Kidney Injury
serum creatinine, serum cystatin C, urine neutrophil gelatinase-associated lipocalin (uNGAL) will be used to asses this outcome measure.
Measured: 48 hours
Rate of Hyperchloremic Metabolic Acidosis
blood pH, base excess (BE), plasma level of Cl will be used to assess this outcome measure.
Measured: 24 hours
Stroke Volume Index
Measured: 24 hours
Rate of Neurological Complications
Delirium, clinically diagnosed stroke, and encephalopathy.
Measured: 24 hours
Blood Loss
Bleeding from chest tubes
Measured: 24 hours
Duration of Mechanical Ventilation
Measured: 24 hours
Chloride Loading
The amount of chloride ions (mmol per patient) which will be infused during the surgery and ICU stay
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Evgeny Fominskiy, MD, PhD, Meshalkin Research Institute of Pathology of Circulation
- Investigators
- Vladimir V Lomivorotov, MD, PhD, Principal investigator, Novosibirsk Research Institute of Pathology of Circulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675453
- Sponsor's protocol ID
- ESHHS
- Acronym
- ESHHS
- Status last verified
- Apr 2016
- First submitted
- 5 Aug 2012
- Last updated
- 27 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lomivorotov VV, Fominskiy EV, Efremov SM, Nepomniashchikh VA, Lomivorotov VN, Chernyavskiy AM, Shilova AN, Karaskov AM. Infusion of 7.2% NaCl/6% hydroxyethyl starch 200/0.5 in on-pump coronary artery bypass surgery patients: a randomized, single-blind pilot study. Shock. 2014 Mar;41(3):193-9. doi: 10.1097/SHK.0000000000000087.
PubMed 24549094
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of 7.2% NaCl Plus 6% Hydroxyethyl 200/0.5 in Patients Scheduled for First-time Coronary Artery Bypass Grafting With Cardiopulmonary Bypass.
- ClinicalTrials.gov ID
- NCT01675453
- Acronym / sponsor ID
- ESHHS / ESHHS
- Conditions
- Coronary Artery Disease, Edema
- Keywords
- Organ dysfunction, Hypertonic solution, Extravascular water, Cardiopulmonary Bypass
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- Jan 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Posted 19 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The organ dysfunction following cardiopulmonary bypass (CPB) occurs frequently in cardiac surgery patients. Systemic inflammatory response initiated by CPB through releasing of several mediators lead to altered endothelial integrity and in consequence the leakage of proteins and fluids from the intravascular to the interstitial compartment is occurred. Increased capillary permeability and decreased colloid osmotic pressure were shown to play a key role for fluid shift and increasing of extravascular water. Further tissue edema can result in injury to many organs, including the heart, lungs, brain, kidneys and can lead to adverse outcomes.
Hypertonic solution creates an osmotic gradient across the cellular membrane, causing a fluid shift from the intracellular and the interstitial spaces of tissue into the intravascular compartment.
The purpose of this study is to investigate the efficacy and safety of 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 in patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7.2% NaCl /hydroxyethyl starch 200/0.5 | Active comparator | Drug: 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) |
| 0.9% NaCl | Placebo comparator | Drug: 0.9% NaClOn-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB) |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients scheduled for first-time coronary artery bypass grafting with cardiopulmonary bypass
Key exclusion criteria (9 listed)
- age >70 years
- body mass index <18 and >35 kg/m2
- left ventricular ejection fraction <40%
- myocardial infarction <6 months before surgery
- stroke or transient ischemic attack <12 months before surgery
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 |
|---|---|---|
| 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5Also: HyperHAES | Drug | 7.2% NaCl /hydroxyethyl starch 200/0.5 |
| 0.9% NaClAlso: Saline | Drug | 0.9% NaCl |
Primary outcome
Extravascular Lung Water Index
Time frame: baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1
Extravascular lung water index (ELWI; mL/kg) will be used to assess this outcome measure. ELWI was monitored by transcardiopulmonary thermodilution technique with the PiCCO plus system. Extravascular lung water represents the extravascular fluid of the lung tissue. It includes intra-cellular, interstitial and intra-alveolar water (not pleural effusion). It is indexed to "Predicted Body Weight".
15 secondary outcomes
Pulmonary Oxygenation
Time frame: 24 hours
Oxygen Delivery
Time frame: 24 hours
Cardiac Index
Time frame: 24 hours
Fluid Balance
Time frame: 24 hours
Inflammation Response
Time frame: 24 hours
Endothelial Integrity
Time frame: 24 hours
Plasma Na
Time frame: 24 hours
Plasma Osmolarity
Time frame: 24 hours
Rate of Acute Kidney Injury
Time frame: 48 hours
Rate of Hyperchloremic Metabolic Acidosis
Time frame: 24 hours
Stroke Volume Index
Time frame: 24 hours
Rate of Neurological Complications
Time frame: 24 hours
Blood Loss
Time frame: 24 hours
Duration of Mechanical Ventilation
Time frame: 24 hours
Chloride Loading
Time frame: 24 h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24549094Lomivorotov VV, Fominskiy EV, Efremov SM, Nepomniashchikh VA, Lomivorotov VN, Chernyavskiy AM, Shilova AN, Karaskov AM. Infusion of 7.2% NaCl/6% hydroxyethyl starch 200/0.5 in on-pump coronary artery bypass surgery patients: a randomized, single-blind pilot study. Shock. 2014 Mar;41(3):193-9. doi: 10.1097/SHK.0000000000000087.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Vladimir V Lomivorotov, MD, PhD principal investigator
Novosibirsk Research Institute of Pathology of Circulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 and 0.9% NaCl in people with Coronary Artery Disease and Edema, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 9 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 27 May 2016. 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 Russia. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Extravascular Lung Water Index (time frame: baseline; 5 min after infusion; 5 min after CPB; 30 min after CPB; end of surgery; 2 h, 4 h, 6 h, 12 h after CPB; Postoperative day 1). 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 NCT01675453, 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 27 May 2016.