Pentoxifylline for Prevention of Contrast Induced Nephropathy in Chronic Kidney Diseased Patients in Intensive Care Unit

The Role of Pentoxifylline for Prevention of Contrast Induced Nephropathy in Chronic Kidney Diseased Patients in Intensive Care Unit

The aim of this study is to evaluate the effect of pentoxifylline for control of contrast induced nephropathy in chronic kidney diseased patients in intensive care unit.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Intensive Care Unit; Contrast Induced Nephropathy; Pentoxifylline
• Intervention / Treatment: Drug: Pentoxifylline; Drug: Normal saline

Detailed Description

Contrast-induced acute kidney injury (AKI), which is also known as contrast-induced nephropathy (CIN), is defined as the development of AKI following contrast medium exposure, without an alternative aetiology.

Recently, the cyclic nucleotide phosphodiesterase (PDE) has emerged as a promising target for pharmacological intervention against chronic kidney disease (CKD) progression.

The nonselective PDE inhibitor pentoxifylline (PTX) is a methyl xanthine derivative. It's an old drug that exhibits prominent anti-inflammatory, anti-proliferative and anti-fibrotic activities both in vitro and in vivo. In addition to its classic indication for intermittent claudication. It has been used primarily to treat patients with peripheral arterial insufficiency.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age from 18 to 65 years.
• Both sexes.
• The presence of chronic kidney disease (CKD) is defined according to the National Kidney Foundation-kidney disease Outcomes Quality Initiative guidelines with second or third stage.
• Urgent patients expected taking dye in stable cases of cardiac catheterization or pulmonary embolism with Geneva score (4-11).

Exclusion Criteria:

• Patients with CKD on renal replacement therapy.
• Respiratory failure.
• Cardiac failure.
• Liver failure.
• Methylxanthines hypersensitivity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I; Patients received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and 400 mg oral Pentoxifylline (PTX) three times per day [dose adjustment according to estimated glomerular filtration rate (eGFR)] from 24 hr before contrast to 48 hr after contrast procedure.	Drug: Pentoxifylline; Patients received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and 400 mg oral Pentoxifylline (PTX) three times per day [dose adjustment according to estimated glomerular filtration rate (eGFR)] from 24 hr before contrast to 48 hr after contrast procedure.
Active Comparator: Group II; Patient received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and placebo with same shape and color of Pentoxifylline (PTX) three times per day from 24 hr before contrast to 48 hr after contrast procedure.	Drug: Normal saline; Patient received hydration (100ml normal saline every hour (2400ml/day) with closed dynamic monitoring of the blood volume and placebo with same shape and color of Pentoxifylline (PTX) three times per day from 24 hr before contrast to 48 hr after contrast procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of contrast induced nephropathy	Incidence of contrast induced nephropathy was recorded.	48 hours after contrast procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress of glomerular filtration rate	Progress of glomerular filtration rate after use of pentoxifylline was recorded.	48 hours after contrast procedure.
Lenght of intensive care unit stay	Lenght of intensive care unit stay was recorded.	Till the end of procedure (Up to 4 hours)
Need of dialysis	Need of dialysis was recorded.	48 hours after contrast procedure.

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): June 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: April 25, 2026
• First Submitted That Met QC Criteria: April 25, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 25, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pharmaceutical Preparations; Purinones; Purines; Crystalloid Solutions; Isotonic Solutions; Solutions; Xanthines; Theobromine; Pentoxifylline; Saline Solution
• Other Study ID Numbers: 36264MS591/5/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No