Effects of Pentoxifylline After Cardiac Surgery

NCT03591536 | Completed DMC

• 1 other identifier: SBU13463
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Oxidative Stress; AKI; Inflammation

Outcome Measures

Primary Outcomes (1)

• change of creatinine level before and after cardiac surgery

  change of serum creatinine level post CABG between pentoxifylline and placebo arms

  change of serum creatinine level 24 hours , 72 hours and 96 hours after cardiac surgery

Secondary Outcomes (3)

• Oxidative stress

  before and 24 hours after end of cardiac surgery

• inflammatory status

  before and 24 hours after end of cardiac surgery

• measuring change of (BMI) weight in kilogram and height in centimeters ratio

  before and after end of cardiopulmonary bypass pomp

Study Arms (2)

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

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

Other: Placebo

Interventions

Pentoxifylline OTHER

400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery

Also known as: pentoxifylline tablets

pentoxifylline oral

Placebo OTHER

oral placebo tablets from 3 days before surgery and on the day of surgery

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The elective CABG candidate

You may not qualify if:

• 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
• sepsis
• renal failure (sCr \> 2 mg/dl),
• hepatic failure (AST (Aspartate transaminase) or ALT(alanine transaminase) \> 40 U/L)
• urinary tract infection.

Sponsors & Collaborators

• nooshin dalili: lead

MeSH Terms

Conditions

Inflammation

Interventions

Pentoxifylline

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: only principle investigator knew the drug from placebo
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of SBMU

Model Details: double blind randomized clinical trial

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: July 19, 2018
• Study Start: January 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: May 1, 2018
• Last Updated: July 19, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share