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

NCT07561801 | Completed

• 1 other identifier: 36264MS591/5/24
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pentoxifylline; Contrast Induced Nephropathy; Chronic Kidney Disease; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Incidence of contrast induced nephropathy

  Incidence of contrast induced nephropathy was recorded.

  48 hours after contrast procedure.

Secondary Outcomes (3)

• Progress of glomerular filtration rate

  48 hours after contrast procedure.

• Lenght of intensive care unit stay

  Till the end of procedure (Up to 4 hours)

• Need of dialysis

  48 hours after contrast procedure.

Study Arms (2)

Group I

EXPERIMENTAL

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

Group II

ACTIVE COMPARATOR

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

Interventions

Pentoxifylline DRUG

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.

Group I

Normal saline DRUG

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.

Group II

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Pentoxifylline; Saline Solution

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Theobromine; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology Surgical Intensive Care and Pain Management, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 25, 2026
• First Posted: May 1, 2026
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)