Oxidative StressNCT03591536
Effects of Pentoxifylline After Cardiac Surgery
A study testing Pentoxifylline in people with Oxidative Stress and AKI, run by nooshin dalili.
Trial summary
Acute Kidney Injury (AKI) is a common and serious post operative complication and may occur in up to 50% of all patients undergoing cardiac surgery and is associated with 8% mortality rate compared with 0.9% in non-affected patients and remains a major factor for post surgery adverse outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxidative Stress, AKI, Inflammation
- What is being tested?
- Pentoxifylline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 1 May 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The elective CABG candidate
Who cannot join
- refusal to sign the consent,
- collagen vascular disease,
- use of immunosuppressive agents, corticosteroids (> 3 days), methylxanthines, diltiazem or sodium nitroprusside,
- angiography in the past 7 days,
- hemorrhagic diathesis and coagulopathy,
- uncontrolled diabetes mellitus
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- sepsis
- renal failure (sCr > 2 mg/dl),
- hepatic failure (AST (Aspartate transaminase) or ALT(alanine transaminase) > 40 U/L)
- urinary tract infection.
About this study
Official title: Effects of Pentoxifylline on Reducing Acute Kidney Injury , Inflammation and Oxidative Stress After Cardiac Surgery
Acute Kidney Injury (AKI) is a common and serious post operative complication and may occur in up to 50% of all patients undergoing cardiac surgery and is associated with 8% mortality rate compared with 0.9% in non-affected patients and remains a major factor for post surgery adverse outcomes. Early interventions to prevent postoperative AKI can help decreasing morbidity and mortality in these patients. Using cardiopulmonary bypass during cardiac surgery triggers systemic inflammatory response and recruits pro-inflammatory cytokines such as tumor necrosis factor, interleukin -10 (IL-10) and Interleukin-6 (IL-6) accompanying with production of free oxygen radicals which provokes oxidative stress in the milieu of ischemic reperfusion injury. Pentoxifylline as a non-specific phosphodiesterase inhibitor, can suppress the production of some factors of inflammatory response and oxidative stress, probably prevent post surgery AKI with these mechanisms.
Read the detailed description
This is a double blind randomized multicenter clinical trial, enrolling 100 consecutive patients undergoing elective Coronary Artery Bypass Graft Surgery (CABG). Patients randomly and within concealment method divided into two groups, one to receive oral pentoxifylline 400 mg every 8 hours from three days before surgery and the other group received placebo. All the intubation , surgery and weaning protocols were the same.
- Conditions
- Oxidative Stress, AKI, Inflammation
- Being tested
- Pentoxifylline, Placebo
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PentoxifyllineOther
Also called pentoxifylline tablets
400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery
PlaceboOther
oral placebo tablets from 3 days before surgery and on the day of surgery
| Study group | Role | What they receive |
|---|---|---|
| pentoxifylline oral | Other | 50 adult patient underwent elective CABG intervention to be administered will be receiving main drug (pentoxifylline )oral 400 mg' every 8 hours from three days before surgery and on the day of surgery effect of intervention regarding antioxidant Receives: Other: Pentoxifylline |
| placebo | Placebo comparator | 50 adult patient underwent elective CABG received oral placebo pill resembling completely to pentoxifylline 400 mg, every 8 hours from three days before surgery and on the day of surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of creatinine level before and after cardiac surgery
change of serum creatinine level post CABG between pentoxifylline and placebo arms
Measured: change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery
Secondary outcomes (3)
Oxidative stress
change of serum malondialdehyde (MDA) level as the inflammatory marker before and 24 hours after cardiac surgery
Measured: before and 24 hours after end of cardiac surgery
inflammatory status
change of serum IL-6 , TNF( tumor necrosis factor) , IL-8 between two arms post cardiac surgery
Measured: before and 24 hours after end of cardiac surgery
measuring change of (BMI) weight in kilogram and height in centimeters ratio
using weight and height ratio for calculating BMI
Measured: before and after end of cardiopulmonary bypass pomp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jan 2017
- Primary completion1 Jun 2017
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized clinical trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- nooshin dalili
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, nooshin dalili, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591536
- Sponsor's protocol ID
- SBU13463
- Status last verified
- Jul 2018
- First submitted
- 23 May 2018
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pentoxifylline on Reducing Acute Kidney Injury , Inflammation and Oxidative Stress After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03591536
- Acronym / sponsor ID
- SBU13463
- Conditions
- Oxidative Stress, AKI, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- nooshin daliliUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 19 Jul 2018 (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.
Acute Kidney Injury (AKI) is a common and serious post operative complication and may occur in up to 50% of all patients undergoing cardiac surgery and is associated with 8% mortality rate compared with 0.9% in non-affected patients and remains a major factor for post surgery adverse outcomes. Early interventions to prevent postoperative AKI can help decreasing morbidity and mortality in these patients. Using cardiopulmonary bypass during cardiac surgery triggers systemic inflammatory response and recruits pro-inflammatory cytokines such as tumor necrosis factor, interleukin -10 (IL-10) and Interleukin-6 (IL-6) accompanying with production of free oxygen radicals which provokes oxidative stress in the milieu of ischemic reperfusion injury. Pentoxifylline as a non-specific phosphodiesterase inhibitor, can suppress the production of some factors of inflammatory response and oxidative stress, probably prevent post surgery AKI with these mechanisms.
Detailed description
This is a double blind randomized multicenter clinical trial, enrolling 100 consecutive patients undergoing elective Coronary Artery Bypass Graft Surgery (CABG). Patients randomly and within concealment method divided into two groups, one to receive oral pentoxifylline 400 mg every 8 hours from three days before surgery and the other group received placebo. All the intubation , surgery and weaning protocols were the same.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- double blind randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| pentoxifylline oral | Other | Other: Pentoxifylline50 adult patient underwent elective CABG intervention to be administered will be receiving main drug (pentoxifylline )oral 400 mg' every 8 hours from three days before surgery and on the day of surgery effect of intervention regarding antioxidant |
| placebo | Placebo comparator | Other: Placebo50 adult patient underwent elective CABG received oral placebo pill resembling completely to pentoxifylline 400 mg, every 8 hours from three days before surgery and on the day of surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The elective CABG candidate
Key exclusion criteria (10 listed)
- refusal to sign the consent,
- collagen vascular disease,
- use of immunosuppressive agents, corticosteroids (> 3 days), methylxanthines, diltiazem or sodium nitroprusside,
- angiography in the past 7 days,
- hemorrhagic diathesis and coagulopathy,
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 |
|---|---|---|
| PentoxifyllineAlso: pentoxifylline tablets400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery | Other | pentoxifylline oral |
| Placebooral placebo tablets from 3 days before surgery and on the day of surgery | Other | placebo |
Primary outcome
change of creatinine level before and after cardiac surgery
Time frame: change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery
change of serum creatinine level post CABG between pentoxifylline and placebo arms
3 secondary outcomes
Oxidative stress
Time frame: before and 24 hours after end of cardiac surgery
inflammatory status
Time frame: before and 24 hours after end of cardiac surgery
measuring change of (BMI) weight in kilogram and height in centimeters ratio
Time frame: before and after end of cardiopulmonary bypass pomp
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 19 Jul 2018.
- Individual participant dataSharing planned: No. no plan
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pentoxifylline in people with Oxidative Stress and AKI, run by nooshin dalili.
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 10 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
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 creatinine level before and after cardiac surgery (time frame: change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery). 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 19 Jul 2018.