HypotensionNCT01532505
Effect of Vasopressin on Tissue Oxygen Saturation in Cardiac Surgery Patients During Cardiopulmonary Bypass
An observational study of Hypotension and Poor Peripheral Perfusion, run by Mohamed Ismail at 1 site in Canada.
Trial summary
The objective of this research is to compare the effect of a low dose Vasopressin infusion or placebo during cardiopulmonary bypass on vasopressor requirements, hemodynamics and tissue oxygen saturation and its recovery using tNIRS and vascular occlusion test (VOT) in elective on pump cardiac surgery patients using a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension, Poor Peripheral Perfusion
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2012to Dec 2012
- Phase
- Observational
- 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
Study population: Stable patients coming from home for elective cardiac surgery are eligible to participate
Who may be able to join
- Adult, elective cardiac surgery patients with the use of cardiopulmonary bypass (CPB)
Who cannot join
- Age less than 18 years
- Contraindication to pneumatic cuff inflation (arteriovenous fistula, previous mastectomy, injury to arm)
- Pregnancy
- Significant peripheral vascular disease of the arms*
- Emergency surgery
- Uncured cancer during chemotherapy
- Lack of informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Hospital, LHSC
London, Ontario, N6A 5A5
Mohamed Ismail, MD, MSc, (519) 494-5133, Mohamed.Ismail@londonhospitals.ca
About this study
Official title: A Randomized Study Comparing Low Dose Vasopressin Infusion or Placebo on Near Infrared Spectroscopy Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients During Cardiopulmonary Bypass: A Pilot Study
The objective of this research is to compare the effect of a low dose Vasopressin infusion or placebo during cardiopulmonary bypass on vasopressor requirements, hemodynamics and tissue oxygen saturation and its recovery using tNIRS and vascular occlusion test (VOT) in elective on pump cardiac surgery patients using a non-invasive near infrared spectrometry (NIRS) machine. The clinical implications are that NIRS may permit earlier, non-invasive detection of significant physiologic derangements and allow more accurate and timely titration of medications, fluids and surgical intervention. The use of a low dose vasopressin seems to be preventive for the incidence of observed post-cardiotomy vasodilatory shock and may improve the function of microcirculation that will be assessed using VOT and tNIRS. Finally, it may decrease both catecholamine dose and duration of their administration, it is considered as a useful agent for decreasing all heir side-effects
Read the detailed description
In our double blind randomized study 40 patients undergoing cardiac surgery will be randomly divided in two groups. The group A who will be infused with 2 IU/hr. vasopressin and the group B who will be infused with normal saline (placebo) intraoperatively starting at the time we give I.V. Heparin, throughout CPB and infusion will be ended when we give the Protamine after coming off bypass. VOTs will be measured at the following time points: Pre-induction of anesthesia, post-induction of anesthesia and at 30 minute intervals during the cardiopulmonary bypass. And we will select cases that are expected to have a longer CPB time such as Redo CABG, CABG + valve replacement, double valve replacement, Bentall procedure and Mitral valve repair with mini thoracotomy.
Measurements of mean artery pressure (MAP), central venous pressure (CVP), ejection fracture (EF), heart rate (HR), mean pulmonary artery pressure (MPAP), cardiac index (CI) will be performed before, during, and after the operation. The requirements of catecholamine support (eg. phenylephrine, epinephrine, vasopressin, norepinephrine, and dopamine) during CPB and for first 24 hours postoperatively, urine-output, blood-loss, and the requirements in blood, plasma and platelets for the first 24 hours will be included in the data collected.
The purpose of the present study is to quantify the micro-oxygenation parameters in patients undergoing cardiac surgery with CPB, to investigate the relationship of micro-oxygenation and macro-perfusion parameters, to investigate the relationship of NIRS parameters and to evaluate the association between micro-oxygenation parameters and outcome using VOT and comparing the degree of falling of re-perfusion slope.
We hypothesize that the administration of a low dose vasopressin will reduce both the incidence and severity of vasoplegia and it will maintain the normal vasomotor reactivity during cardiopulmonary bypass and this will reduce the total requirements of alpha-adrenergic agonists specially Phenylephrine. That will reduce the risks of the use of high dose of Phenylephrine and other inotropes, such as gut ischemia and end organ damage.
Vascular Occlusion Test (VOT)
- After the tissue oximetry probe is applied to the skin the oximeter machine records a baseline value.
- A pneumatic cuff (blood pressure cuff) is placed over the brachial artery of the same arm above the elbow and inflated to 50 mmHg above systolic blood pressure. The cuff remains inflated for 5 minutes. The oximeter machine is continuously recording StO2 values and other pertinent technical information such as quality of the signal and events marked by the user.
- After 5 minutes the cuff is quickly deflated and StO2 measurements continue to be recorded until back to baseline.
- VOTs will be measured at the following time points:
- Pre-induction of anesthesia
- Post-induction of anesthesia
- At 30 minute intervals during the cardiopulmonary bypass
Several measurements and calculations will be made from the recorded data:
- Baseline tissue oxygen saturation (StO2baseline) at time (t) = 0
- Lowest StO2 reached after vascular occlusion (StO2nadir) and at what time
- Occlusion slope: defined as = (StO2baseline - StO2nadir/tbaseline - tnadir)
- After cuff release, time at which baseline StO2 was reached (StO2recovery)
- Reperfusion slope: defined as = (StO2recovery - StO2nadir/trecovery - tnadir)
- ∆StO2: defined as = (StO2peak - StO2baseline)
- Peak StO2 reached after cuff release and at what time
Measurements of mean artery pressure (MAP), central venous pressure (CVP), ejection fracture (EF), heart rate (HR), mean pulmonary artery pressure (MPAP), cardiac index (CI) will be performed before, during, and after the operation. The requirements of catecholamine support (eg. phenylephrine, epinephrine, vasopressin, norepinephrine, dopamine) during CPB and for first 24 hours postoperatively, urine-output, blood-loss, and the requirements in blood, plasma and platelets for the first 24 hours will be included in the data collected.
- Conditions
- Hypotension, Poor Peripheral Perfusion
- Keywords
- cardiopulmonary bypass, Postcardiotomy vasodilatory shock, Microcirculation, Catecholamines, Vasopressin
- Medical subject headings
- Hypotension, Diabetes Insipidus
What is being measured
The primary outcome is the main question the study is designed to answer.
VOT assessment of microcirculation
change in reperfusion slope of VOT will be assessed each 30 min during CPB and compared between vasopressin and placebo patients
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohamed Ismail
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Sponsor-investigator, Mohamed Ismail, London Health Sciences Centre
- Investigators
- MOHAMED ISMAIL, MD,MSc, Principal investigator, London HSCJOHN MURKIN, MD, FRCPC, Study director, London HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532505
- Sponsor's protocol ID
- 18511
- Status last verified
- Feb 2012
- First submitted
- 19 Jan 2012
- Last updated
- 15 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peripheral Tissue Oxygen Saturation (SaO2) Monitoring and the Vascular Occlusion Test in Cardiac Surgery: A Pilot Study. Smith R, Murkin J, Granton J, Guo LR, McKenzie FN, Min F, Zhang R. ASA Chicago, Oct 15-19, 2011, Anesthesiology 2011 A278.
Papadopoulos G, Sintou E, Siminelakis S, Koletsis E, Baikoussis NG, Apostolakis E. Perioperative infusion of low- dose of vasopressin for prevention and management of vasodilatory vasoplegic syndrome in patients undergoing coronary artery bypass grafting-A double-blind randomized study. J Cardiothorac Surg. 2010 Mar 28;5:17. doi: 10.1186/1749-8090-5-17.
PubMed 20346182
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Comparing Low Dose Vasopressin Infusion or Placebo on Near Infrared Spectroscopy Tissue Oxygen Saturation and the Vascular Occlusion Test in Cardiac Surgery Patients During Cardiopulmonary Bypass: A Pilot Study
- ClinicalTrials.gov ID
- NCT01532505
- Acronym / sponsor ID
- 18511
- Conditions
- Hypotension, Poor Peripheral Perfusion
- Keywords
- cardiopulmonary bypass, Postcardiotomy vasodilatory shock, Microcirculation, Catecholamines, Vasopressin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mohamed IsmailUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 14 Feb 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.
The objective of this research is to compare the effect of a low dose Vasopressin infusion or placebo during cardiopulmonary bypass on vasopressor requirements, hemodynamics and tissue oxygen saturation and its recovery using tNIRS and vascular occlusion test (VOT) in elective on pump cardiac surgery patients using a non-invasive near infrared spectrometry (NIRS) machine. The clinical implications are that NIRS may permit earlier, non-invasive detection of significant physiologic derangements and allow more accurate and timely titration of medications, fluids and surgical intervention. The use of a low dose vasopressin seems to be preventive for the incidence of observed post-cardiotomy vasodilatory shock and may improve the function of microcirculation that will be assessed using VOT and tNIRS. Finally, it may decrease both catecholamine dose and duration of their administration, it is considered as a useful agent for decreasing all heir side-effects
Detailed description
In our double blind randomized study 40 patients undergoing cardiac surgery will be randomly divided in two groups. The group A who will be infused with 2 IU/hr. vasopressin and the group B who will be infused with normal saline (placebo) intraoperatively starting at the time we give I.V. Heparin, throughout CPB and infusion will be ended when we give the Protamine after coming off bypass. VOTs will be measured at the following time points: Pre-induction of anesthesia, post-induction of anesthesia and at 30 minute intervals during the cardiopulmonary bypass. And we will select cases that are expected to have a longer CPB time such as Redo CABG, CABG + valve replacement, double valve replacement, Bentall procedure and Mitral valve repair with mini thoracotomy.
Measurements of mean artery pressure (MAP), central venous pressure (CVP), ejection fracture (EF), heart rate (HR), mean pulmonary artery pressure (MPAP), cardiac index (CI) will be performed before, during, and after the operation. The requirements of catecholamine support (eg. phenylephrine, epinephrine, vasopressin, norepinephrine, and dopamine) during CPB and for first 24 hours postoperatively, urine-output, blood-loss, and the requirements in blood, plasma and platelets for the first 24 hours will be included in the data collected.
The purpose of the present study is to quantify the micro-oxygenation parameters in patients undergoing cardiac surgery with CPB, to investigate the relationship of micro-oxygenation and macro-perfusion parameters, to investigate the relationship of NIRS parameters and to evaluate the association between micro-oxygenation parameters and outcome using VOT and comparing the degree of falling of re-perfusion slope.
We hypothesize that the administration of a low dose vasopressin will reduce both the incidence and severity of vasoplegia and it will maintain the normal vasomotor reactivity during cardiopulmonary bypass and this will reduce the total requirements of alpha-adrenergic agonists specially Phenylephrine. That will reduce the risks of the use of high dose of Phenylephrine and other inotropes, such as gut ischemia and end organ damage.
Vascular Occlusion Test (VOT)
- After the tissue oximetry probe is applied to the skin the oximeter machine records a baseline value.
- A pneumatic cuff (blood pressure cuff) is placed over the brachial artery of the same arm above the elbow and inflated to 50 mmHg above systolic blood pressure. The cuff remains inflated for 5 minutes. The oximeter machine is continuously recording StO2 values and other pertinent technical information such as quality of the signal and events marked by the user.
- After 5 minutes the cuff is quickly deflated and StO2 measurements continue to be recorded until back to baseline.
- VOTs will be measured at the following time points:
- Pre-induction of anesthesia
- Post-induction of anesthesia
- At 30 minute intervals during the cardiopulmonary bypass
Several measurements and calculations will be made from the recorded data:
- Baseline tissue oxygen saturation (StO2baseline) at time (t) = 0
- Lowest StO2 reached after vascular occlusion (StO2nadir) and at what time
- Occlusion slope: defined as = (StO2baseline - StO2nadir/tbaseline - tnadir)
- After cuff release, time at which baseline StO2 was reached (StO2recovery)
- Reperfusion slope: defined as = (StO2recovery - StO2nadir/trecovery - tnadir)
- ∆StO2: defined as = (StO2peak - StO2baseline)
- Peak StO2 reached after cuff release and at what time
Measurements of mean artery pressure (MAP), central venous pressure (CVP), ejection fracture (EF), heart rate (HR), mean pulmonary artery pressure (MPAP), cardiac index (CI) will be performed before, during, and after the operation. The requirements of catecholamine support (eg. phenylephrine, epinephrine, vasopressin, norepinephrine, dopamine) during CPB and for first 24 hours postoperatively, urine-output, blood-loss, and the requirements in blood, plasma and platelets for the first 24 hours will be included in the data collected.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable patients coming from home for elective cardiac surgery are eligible to participate
Key inclusion criteria (1 listed)
- Adult, elective cardiac surgery patients with the use of cardiopulmonary bypass (CPB)
Key exclusion criteria (7 listed)
- Age less than 18 years
- Contraindication to pneumatic cuff inflation (arteriovenous fistula, previous mastectomy, injury to arm)
- Pregnancy
- Significant peripheral vascular disease of the arms*
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VOT assessment of microcirculation
Time frame: day one
change in reperfusion slope of VOT will be assessed each 30 min during CPB and compared between vasopressin and placebo patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
- BackgroundPeripheral Tissue Oxygen Saturation (SaO2) Monitoring and the Vascular Occlusion Test in Cardiac Surgery: A Pilot Study. Smith R, Murkin J, Granton J, Guo LR, McKenzie FN, Min F, Zhang R. ASA Chicago, Oct 15-19, 2011, Anesthesiology 2011 A278.
- Background: PubMed 20346182Papadopoulos G, Sintou E, Siminelakis S, Koletsis E, Baikoussis NG, Apostolakis E. Perioperative infusion of low- dose of vasopressin for prevention and management of vasodilatory vasoplegic syndrome in patients undergoing coronary artery bypass grafting-A double-blind randomized study. J Cardiothorac Surg. 2010 Mar 28;5:17. doi: 10.1186/1749-8090-5-17.
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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.
MOHAMED ISMAIL, MD,MSc principal investigator
London HSC
JOHN MURKIN, MD, FRCPC study director
London HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypotension and Poor Peripheral Perfusion, run by Mohamed Ismail at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 15 Feb 2012. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VOT assessment of microcirculation (time frame: day one). 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 NCT01532505, which also lists 2 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 15 Feb 2012.