Alteplase for Percutaneous Treatment of Loculated Abdominopelvic Abscesses

Status Completed

Clinical Trial Summary

Intracavitary injection of low dose alteplase into loculated abdominopelvic abscesses will reduce the duration of percutaneous drainage and increase the proportion of successful drainages.

Clinical Trial Description

The use of fibrinolytics for the percutaneous drainage of loculated pleural effusions has been shown to reduce the catheter dwell time and to improve drainage of the effusions. Abscesses in the abdomen and pelvis are often loculated which makes percutaneous drainage difficult. We hypothesize that the infusion of alteplase via a drainage catheter into the loculated abscess collections of the abdomen and pelvis will similarly decrease catheter dwell time and improve overall abscess drainage. The direct injection of Activase into abscess cavities utilizes a very low dose of drug within a closed environment which should not be associated with any significant risk of hemorrhage. To date, there does not appear to be a significant risk of systemic hemorrhagic complications associated with the use of intracavitary thrombolytics for the drainage of abdominopelvic abscesses although only a few such studies have been reported. We hope to prove that the use alteplase for intracavitary thrombolysis improves outcomes associated with percutaneous catheter drainage of loculated abscess collections without increasing complications or costs.

The design of the trial will be as a single-center, prospective, open-label, randomized trial comparing the infusion of Activase versus saline for treatment of loculated abdominopelvic abscesses requiring percutaneous drainage. Patients with loculated abdominopelvic abscesses who are referred for percutaneous drainage will be eligible for this study. Patients will undergo standard placement of a 10-12 french percutaneous drain into their abscess cavity under computed tomography guidance. If the entire contents of the abscess cavity cannot be aspirated at the time of initial catheter placement, the abscess will be assumed to be loculated. The patient will then be randomized to have their abscess catheter irrigated twice a day with a volume of fluid approximately equal to the one-half the residual volume of the abscess. In the control group, the normal saline will be fluid instilled into the abscess cavity. The study group will receive Activase reconstituted in sterile water and then diluted to the appropriate volume with normal saline. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00284739
Study type	Interventional
Source	Kaiser Permanente
Contact
Status	Completed
Phase	Phase 2
Start date	February 2006
Completion date	October 2007

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00515034` - A Safety and Tolerability Study of Doripenem in Patients With Abdominal Infections or Pneumonia	Phase 2
Recruiting	`NCT02688244` - Irrigation Versus Suction in Complicated Acute Appendicitis	N/A
Completed	`NCT01568853` - A Prospective Study of The Complement Depletion in Patients With Severe Abdominal Sepsis	N/A
Completed	`NCT00136201` - Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections	Phase 3
Completed	`NCT00931554` - Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections	N/A
Completed	`NCT03681665` - Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT
Completed	`NCT01597336` - Treatment of Abdominal Abscesses With or Without Fibrinolysis	N/A
Completed	`NCT01283815` - Laparoscopic Management of Periappendicular Abscess	Phase 2
Completed	`NCT05283733` - Open to Laparoscopic Reverse Conversion of Perforated Appendicitis	N/A
Terminated	`NCT01110382` - A Safety and Tolerability Study of Doripenem Compared With Meropenem in Children Hospitalized With Complicated Intra-abdominal Infections	Phase 3
Completed	`NCT00488306` - Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI	Phase 4
Recruiting	`NCT03815370` - A Non-Traumatic Binder for Temporary Abdominal Wall Closure	N/A
Recruiting	`NCT03476941` - Antibiotic Irrigations for Intra-Abdominal Drains	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.