Heart Valve DiseasesNCT00745810
Anesthetic Management and Remote Reperfusion Injuries
An observational study of Heart Valve Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Ischemia- reperfusion ( IR ) injuries were not only seen in the transplanted organs but also the remote organs such as lungs that brings major postoperative complications. Severe complications such as pulmonary infiltration and pulmonary edema following reperfusion were frequently associated with liver… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Cardiopulmonary bypass
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2008to Dec 2010
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who receive an open heart surgery under cardiopulmonary bypass
Who may be able to join
- age > 20 y/0, need cardiopulmonary bypass
Who cannot join
- severe anemia, hematologic diseases, hormone therapy, previous valvular surgery, blood transfusion in recent 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Anesthetic Management on Oxidative Injuries After Cardiopulmonary Bypass
Ischemia- reperfusion ( IR ) injuries were not only seen in the transplanted organs but also the remote organs such as lungs that brings major postoperative complications. Severe complications such as pulmonary infiltration and pulmonary edema following reperfusion were frequently associated with liver transplantation. Cardiac surgery performed with the use of cardiopulmonary bypass ( CPB ) provokes a systemic inflammatory response syndrome that affects postoperative pulmonary, myocardiac and renal functions. Previous study about the reperfusion injuries was focused on the leukocyte and endothelial activation and the following oxidative injuries, however, the alteration on pulmonary function such as dynamic compliance and the oxidative/antioxidative balance in erythrocytes and the following effects in CPB have not been fully studied. Erythrocytes' reaction to oxidative stress including cytoplasma and cell membrane should be studied because RBCs are the major circulating blood cells having different types of antioxidant system to capture reactive oxygen species ( ROS ) thus RBC may be severely injured by ROS or protected ROS injuries during CPB. In these three-year study, we plan to explore the extent and pattern of remote oxidative injuries in lungs by massive ROS production and the following products released from reperfused organs. In the first year, the remote pulmonary injuries from hepatic IR will be focused. We plan to establish an animal model for pulmonary function and pulmonary injury assessments including dynamic compliance (Cdyn), pulmonary edema wet-to-dry ratio (W/D), malondialdehyde (MDA) and histopathological findings under hepatic IR challenge. In the second year, the IR effects during and after CPB on circulating blood cells will be fully studied. We plan to investigate the magnitude, subtypes and timing on ROS production, the changes of oxidative and antioxidant activities of erythrocytes including cytoplasma and cell membrane, the changes on leukocytes and plasma to explore the roles of circulating erythrocytes on oxidative stress in CPB. In the third year, we plan to try propofol, stated having antioxidant in vivo and in vitro, on the remote pulmonary injuries following hepatic IR and CPB.
Read the detailed description
Seven ml blood sample were taken from arterial line after stabilization of anesthesia (T1), 30 minutes after total CPB (T2), one hour after weaning from CPB (T3) and 24 hours after weaning from CPB (T4). One ml blood sample was immediately wrapped in aluminum foil and kept in ice to immediate measurements of MetHb, COHb and CL (ROS). CL assay was carried out within 2 hours of sampling. Six ml samples remained was placed into tubes containing ethylenediamine tetraacetic acid. Serum were separated ( at 2000rpm for 10 minutes) immediately after sampling and stored at -80℃ for TAS assay, cytokine measurements, malondialdehyde (MDA) determination, complements and leukocyte elastase measurements. Those assay and measurements were carried out within 4 weeks of surgery.
Measurements of hemoglobin (Hb), COHb and MetHb: Hb, COHb and MetHb were measured immediately with ABL520, Radiometer, Copenhagen, Denmark).
Measurement of Redox balance: 0.2ml of fresh drawn blood was used to measure ROS production by lucigenin Chemiluminescence (CL) (detecting superoxide mainly) and luminal CL (detecting H2O2 and HOCl mainly) as previous study.The total antioxidant status in 20 uL of plasma was measured with a total antioxidant status (TAS) kit ( TAS CAL, Randox). Hemodilution effects with CPB, TAS levels at T2 were corrected with the hematocrits. Lipid peroxidation was determined by the thiobarbiturate reaction measuring the formation of MDA in plasma by TBARS assay kit (Cayman chemical co. USA) Cytokines analysis: Inflammatory cytokines were analysis with RayBio human inflammation antibody array 3 according to the manufacturer's instruction. (Cat# AAH-INF-3, RayBiotech Inc. Norcross, GA, USA).29 Measurements of complement activation and leukocytes activation: Complement Component 3a (C3a), C5a, and Human Terminal Complement Complex C5b-9 (C5b-9) were measured with human C3a EIA kit, human C5a EIA kit, Human Terminal Complement Complex C5b-9 kit, Life Science Inc.). Leukocyte elastase were measured by Elisa kit for Human Elastase 2,Neutrophil(NE, Life Science Inc.)
- Conditions
- Heart Valve Diseases
- Being tested
- Cardiopulmonary bypass
- Keywords
- cardiopulmonary bypass, oxidative injuries
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary bypassOther
Also called oxidative injuries, inflammatory cytokines, complements, leukocyte elastase
sequential changes of oxidative injuries before and after cardiopulmonary bypass
| Study group | Role | What they receive |
|---|---|---|
| 1 | sequential changes before and after cardiopulmonary bypass including ROS, antioxidant status, leukocyte elastase, complements, inflammatory cytokines Receives: Other: Cardiopulmonary bypass |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2008 (estimated)
- Study startAug 2008
- Primary completionNov 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ya-jung cheng, PhD, Principal investigator, Department of anesthesia, national taiwan university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00745810
- Sponsor's protocol ID
- 200705022R
- Status last verified
- Jun 2011
- First submitted
- 31 Aug 2008
- Last updated
- 17 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Anesthetic Management on Oxidative Injuries After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00745810
- Acronym / sponsor ID
- 200705022R
- Conditions
- Heart Valve Diseases
- Keywords
- cardiopulmonary bypass, oxidative injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 3 Sep 2008 (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.
Ischemia- reperfusion ( IR ) injuries were not only seen in the transplanted organs but also the remote organs such as lungs that brings major postoperative complications. Severe complications such as pulmonary infiltration and pulmonary edema following reperfusion were frequently associated with liver transplantation. Cardiac surgery performed with the use of cardiopulmonary bypass ( CPB ) provokes a systemic inflammatory response syndrome that affects postoperative pulmonary, myocardiac and renal functions. Previous study about the reperfusion injuries was focused on the leukocyte and endothelial activation and the following oxidative injuries, however, the alteration on pulmonary function such as dynamic compliance and the oxidative/antioxidative balance in erythrocytes and the following effects in CPB have not been fully studied. Erythrocytes' reaction to oxidative stress including cytoplasma and cell membrane should be studied because RBCs are the major circulating blood cells having different types of antioxidant system to capture reactive oxygen species ( ROS ) thus RBC may be severely injured by ROS or protected ROS injuries during CPB. In these three-year study, we plan to explore the extent and pattern of remote oxidative injuries in lungs by massive ROS production and the following products released from reperfused organs. In the first year, the remote pulmonary injuries from hepatic IR will be focused. We plan to establish an animal model for pulmonary function and pulmonary injury assessments including dynamic compliance (Cdyn), pulmonary edema wet-to-dry ratio (W/D), malondialdehyde (MDA) and histopathological findings under hepatic IR challenge. In the second year, the IR effects during and after CPB on circulating blood cells will be fully studied. We plan to investigate the magnitude, subtypes and timing on ROS production, the changes of oxidative and antioxidant activities of erythrocytes including cytoplasma and cell membrane, the changes on leukocytes and plasma to explore the roles of circulating erythrocytes on oxidative stress in CPB. In the third year, we plan to try propofol, stated having antioxidant in vivo and in vitro, on the remote pulmonary injuries following hepatic IR and CPB.
Detailed description
Seven ml blood sample were taken from arterial line after stabilization of anesthesia (T1), 30 minutes after total CPB (T2), one hour after weaning from CPB (T3) and 24 hours after weaning from CPB (T4). One ml blood sample was immediately wrapped in aluminum foil and kept in ice to immediate measurements of MetHb, COHb and CL (ROS). CL assay was carried out within 2 hours of sampling. Six ml samples remained was placed into tubes containing ethylenediamine tetraacetic acid. Serum were separated ( at 2000rpm for 10 minutes) immediately after sampling and stored at -80℃ for TAS assay, cytokine measurements, malondialdehyde (MDA) determination, complements and leukocyte elastase measurements. Those assay and measurements were carried out within 4 weeks of surgery.
Measurements of hemoglobin (Hb), COHb and MetHb: Hb, COHb and MetHb were measured immediately with ABL520, Radiometer, Copenhagen, Denmark).
Measurement of Redox balance: 0.2ml of fresh drawn blood was used to measure ROS production by lucigenin Chemiluminescence (CL) (detecting superoxide mainly) and luminal CL (detecting H2O2 and HOCl mainly) as previous study.The total antioxidant status in 20 uL of plasma was measured with a total antioxidant status (TAS) kit ( TAS CAL, Randox). Hemodilution effects with CPB, TAS levels at T2 were corrected with the hematocrits. Lipid peroxidation was determined by the thiobarbiturate reaction measuring the formation of MDA in plasma by TBARS assay kit (Cayman chemical co. USA) Cytokines analysis: Inflammatory cytokines were analysis with RayBio human inflammation antibody array 3 according to the manufacturer's instruction. (Cat# AAH-INF-3, RayBiotech Inc. Norcross, GA, USA).29 Measurements of complement activation and leukocytes activation: Complement Component 3a (C3a), C5a, and Human Terminal Complement Complex C5b-9 (C5b-9) were measured with human C3a EIA kit, human C5a EIA kit, Human Terminal Complement Complex C5b-9 kit, Life Science Inc.). Leukocyte elastase were measured by Elisa kit for Human Elastase 2,Neutrophil(NE, Life Science Inc.)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: Cardiopulmonary bypasssequential changes before and after cardiopulmonary bypass including ROS, antioxidant status, leukocyte elastase, complements, inflammatory cytokines |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who receive an open heart surgery under cardiopulmonary bypass
Key inclusion criteria (1 listed)
- age > 20 y/0, need cardiopulmonary bypass
Key exclusion criteria (1 listed)
- severe anemia, hematologic diseases, hormone therapy, previous valvular surgery, blood transfusion in recent 3 months
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 |
|---|---|---|
| Cardiopulmonary bypassAlso: oxidative injuries, inflammatory cytokines, complements, leukocyte elastasesequential changes of oxidative injuries before and after cardiopulmonary bypass | Other | 1 |
Primary outcome
Not reported in the source record.
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 17 Oct 2011.
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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.
ya-jung cheng, PhD principal investigator
Department of anesthesia, national taiwan university hospital
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 Heart Valve Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
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 1 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 17 Oct 2011. 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 Taiwan. 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.
Where can I read the original study information?
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 17 Oct 2011.