Neutrophil Lymphocyte RatioNCT03097692
Does Preconditioning Affects Other Organs in Patients Undergoing Open Heart Surgery ?
A study testing ischemic preconditioning and Pharmacologic preconditionig in people with Neutrophil Lymphocyte Ratio and Serum Createnine, run by Assiut University at 1 site in Egypt.
Trial summary
An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neutrophil Lymphocyte Ratio, Serum Createnine, Mechanical Ventilation
- What is being tested?
- ischemic preconditioning and Pharmacologic preconditionig
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- May 2016to Mar 2017
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery
- no active inflammatory process
Who cannot join
- Emergency surgery
- Clinically significant kidney or liver disease
- Patients allergic to local anesthetic
- Patients with prolonged cardiopulmonary bypass time (>120 min)
- Patients required intra-aortic balloon pump
- Postoperative hemodynamic instability (including the occurrence of serious arrhythmia) or bleeding that required surgical re-exploration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Variable Types of Preconditioning,is There a Different Impact Upon Multiorgan Function After Open Heart Surgery ?
An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation
Read the detailed description
Preliminary evidence has suggested the role of inflammation in development and prognosis of cardiovascular diseases and cancers. Most of the prognostic studies failed to account for the effects of co-morbid conditions as these might have raised the systemic inflammation. We used neutrophil lymphocyte ratio (NLR) as a measure of systemic inflammation and investigated its association with cardiac preconditioning in open heart surgery .
- Being tested
- ischemic preconditioning, Pharmacologic preconditionig
- Keywords
- cardiac preconditioning, open heart surgery, createnine, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ischemic preconditioningProcedure or surgery
ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
Pharmacologic preconditionigDrug
Pharmacologic preconditionig will be attained by sevoflurane anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Ischemic preconditioing | Active comparator | 50 patients ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles Receives: Procedure: ischemic preconditioning |
| Pharmacologic preconditioing | Active comparator | by sevoflurane anesthesia Receives: Drug: Pharmacologic preconditionig |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Neutrophil lymphocyte ratio
Measured: during first two postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study startMay 2016
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutrophil Lymphocyte RatioStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group well be pretreated with cardiac preconditioning
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097692
- Sponsor's protocol ID
- IRB00009909
- Status last verified
- Dec 2017
- First submitted
- 21 Mar 2017
- Last updated
- 21 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variable Types of Preconditioning,is There a Different Impact Upon Multiorgan Function After Open Heart Surgery ?
- ClinicalTrials.gov ID
- NCT03097692
- Acronym / sponsor ID
- IRB00009909
- Keywords
- cardiac preconditioning, open heart surgery, createnine, inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 31 Mar 2017 (actual)
- 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.
An association between white blood cell count (WBC), neutrophil-lymphocyte ratio , and inflammatory process is well known . Ischemic preconditioning reduces the inflammation
Detailed description
Preliminary evidence has suggested the role of inflammation in development and prognosis of cardiovascular diseases and cancers. Most of the prognostic studies failed to account for the effects of co-morbid conditions as these might have raised the systemic inflammation. We used neutrophil lymphocyte ratio (NLR) as a measure of systemic inflammation and investigated its association with cardiac preconditioning in open heart surgery .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- intervention group well be pretreated with cardiac preconditioning
| Arm | Type | Receives |
|---|---|---|
| Ischemic preconditioing | Active comparator | Procedure: ischemic preconditioning50 patients ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles |
| Pharmacologic preconditioing | Active comparator | Drug: Pharmacologic preconditionigby sevoflurane anesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-60 years old
- American Society of Anesthesiologists physical status II and III
- Patients scheduled for open heart surgery
- no active inflammatory process
Key exclusion criteria (6 listed)
- Emergency surgery
- Clinically significant kidney or liver disease
- Patients allergic to local anesthetic
- Patients with prolonged cardiopulmonary bypass time (>120 min)
- Patients required intra-aortic balloon pump
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 |
|---|---|---|
| ischemic preconditioningischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles | Procedure or surgery | Ischemic preconditioing |
| Pharmacologic preconditionigPharmacologic preconditionig will be attained by sevoflurane anesthesia | Drug | Pharmacologic preconditioing |
Primary outcome
change of Neutrophil lymphocyte ratio
Time frame: during first two postoperative days
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 21 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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 study testing ischemic preconditioning and Pharmacologic preconditionig in people with Neutrophil Lymphocyte Ratio and Serum Createnine, run by Assiut University at 1 site in Egypt.
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 4 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 21 Dec 2017. 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 Egypt. 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 of Neutrophil lymphocyte ratio (time frame: during first two postoperative days). It is what the study was designed to measure, not a finding.
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 21 Dec 2017.