Treatment Trials

45 Clinical Trials for Various Conditions

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WITHDRAWN
EZIO Compared to Central Venous Lines for Emergency Vascular Access
Description

Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.

COMPLETED
Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices
Description

This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment.

COMPLETED
A Randomized Evaluation of the Effect of Routine Normal Saline Flush Versus Heparinized Saline Solution in Groshong and Groshong PICC Catheters
Description

The Groshong and Groshong PICC catheters are popular venous access devices because they are maintained with only weekly saline flushes. In a recent study, however, we found an apparent decrease in the rate of withdrawal occlusion in Groshong catheters flushed weekly with heparinized saline. However, a randomized trial is necessary to confirm this impression. In the current study as many as 66 patients will be randomized to each of two treatment arms. The Groshong catheters of one group will be flushed with saline only and the other group with heparinized saline. A comparison will be made between the frequency with which urokinase is used in the two groups to treat withdrawal occlusion during the first three months of catheterization. Groshong catheters using saline flushes will be compared to Groshong catheters using heparinized saline flushes and Groshong PICC catheters using saline flushes will be compared to Groshong PICC catheters using heparinized saline flushes. Data will be analyzed using Fisher's exact test.

TERMINATED
Continuous Intercostal Nerve Blockade for Traumatic Rib Fractures
Description

Rib fractures are common injuries in accident patients and can be associated with significant pain during recovery. If poorly controlled, pain from splinting due to rib fractures can result in difficulty in breathing leading to incomplete expansion of lung, and even the need to put a patient on a ventilator to help them breathe. Therefore, pain control is critical in managing patients with rib fractures. To date, many studies have shown the effectiveness of continuous intercostal nerve blockade (a slow release of pain medications at the site of injury that prevents the transmission of pain signals). This approach has never been studied in a randomized fashion in rib fracture patients, and has never been compared to patient-controlled narcotic pain medication, commonly used at many hospitals. The purpose of this study is to evaluate the effectiveness of the placement of an elastomeric infusion pump (a small, external, wearable balloon used to deliver medication over time) attached to a continuous infusion catheter or "soaker" catheter (a tube which releases the pain medication through tiny holes in it, right at the site of injury) to deliver local anesthetic medication to reduce pain caused by two or more rib fractures.

Conditions
COMPLETED
Early or Late Foley Removal After Thoracotomy
Description

Is the early removal of Foley catheter safe in patients undergoing general thoracic surgery with an epidural catheter in place?

WITHDRAWN
Clinical Evaluation of the Ultrasound-Guided Retroclavicular Brachial Plexus Block
Description

The primary objective of this prospective, descriptive study is to evaluate the success rate of the retroclavicular brachial plexus block and catheter placement in 60 adult patients undergoing hand, wrist, or forearm surgery. The investigators will also evaluate any difficulties performing the procedure, the onset time and distribution of the block, incidence of adverse events, and patient's acceptance of the block.

COMPLETED
Comparison of Infection Rates Among Patients Using Two Catheter Access Devices
Description

Intravenous catheters are placed in nearly every hospitalized patient. These catheters, since they are breaks in skin integrity, are potential sources of infection that occur in the bloodstream. Bloodstream infections can result in higher rates of death and lengths of hospital stay, as well as increase healthcare costs. Blood is drawn or medications delivered through a catheter access device attached to the catheter. In looking at new ways to decrease infections associated with healthcare, the investigators plan to test whether the use of a silver-coated catheter access device (VLINK) compared to the standard, non-coated device (CLEARLINK) can reduce infection rates. These devices are identical in design other than the silver coating of the VLINK, that imparts a brown color to the device. Silver can prevent the growth of bacteria inside the device (biofilm formation) in the laboratory, but this has never been proven in patients. The investigators propose to do a crossover study in two Emory-owned hospitals (Emory University Hospital and Emory University Hospital at Midtown), anticipated to last 10 months. Currently, both types of devices, (standard and silver-coated) are FDA approved for clinical use and are in use at both hospitals. The investigators plan to have each hospital use only one type of catheter access device for a period of time (approximately 5 months), and then switch ("crossover") to other type of device for the rest of the study. All patients admitted to either hospital (excluding newborns and patients with infections attributed to hemodialysis catheters) will be enrolled since both devices meet the standard of care. During the study, the infection prevention department, as a continuing part of their regular duties will measure infection rates. A small subset of catheters that are removed during routine clinical care (none will be taken out solely for the study) will be sent to CDC to determine the amount of bacteria inside catheters and catheter access devices (look for biofilm). Finally, the microbiology lab, again as part of its routine function will determine the rate at which blood cultures are falsely positive. All of these measures will be compared using statistical methods to see if there is a difference between the standard and silver-coated catheter access devices. In undertaking this study, the investigators will be using a type of vascular access device (valve, not positive pressure) already in use in both hospitals and not changing the delivery of care to patients while, in a rigorous, systematic manner, obtaining samples and data for analysis.

COMPLETED
Intraventricular Rt-PA in Patients With Intraventricular Hemorrhage
Description

This is a study to evaluate how recombinant tissue plasminogen activator (rt-PA) is utilized in patients with intraventricular hemorrhage (IVH). rt-PA is a drug that has been shown to dissolve blood, and may allow intraventricular catheters to be more effective for a longer period of time.

RECRUITING
Function of Tamsulosin in Older Males Undergoing Surgery With Indwelling Catheter
Description

This study is being done to answer the question: What is the impact of a medication called tamsulosin (also called Flomax) on the rate of postoperative urinary retention (POUR) and catheter-associated urinary tract infection (UTI)? One of the most common complications following surgery and associated with Foley catheters is post-operative urinary retention (POUR) after the catheter is removed. This is defined as being unable to urinate spontaneously within 8 hours following the removal of the indwelling Foley catheter (the catheter that sits in your bladder to drain urine after surgery). When this happens, it requires intermittent straight catheterization of the bladder (placing a temporary catheter in the bladder to drain the buildup of urine), which can cause a lot of discomfort and anxiety, as well as increase the risk of catheter-associated urinary tract infection (CAUTI).

RECRUITING
Intravesical Lactobacillus for Urinary Symptoms Among People with NLUTD Who Use Indwelling Catheters
Description

The objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical Lactobacillus RhamnosusGG (LGG®) dose to be used to reduce urinary symptoms in a future clinical trial.

UNKNOWN
Talc Outpatient Pleurodesis With Indwelling Catheter
Description

This study will be a prospective, randomized trial comparing a new protocol to the standard of care. The investigators protocol and the standard of care involves a previously established procedure that will be completed in the investigators pulmonary procedure unit. The study will include using previously, well-established procedures (indwelling pleural catheter placement, talc slurry administration through an indwelling pleural catheter, pleuroscopy with talc poudrage administration) in addition to a new protocol (at home continuous drainage via indwelling pleural catheter).

TERMINATED
Exparel Interscalene vs Indwelling Catheter
Description

The investigators are comparing an indwelling catheter with intermediate duration local anesthetic to a single shot peripheral nerve block with long acting a local anesthetic (Exparel).

Conditions
TERMINATED
Betadine Bladder Irrigations vs. Standard of Care Prior to Indwelling Catheter Removal
Description

Over the last decade, there has been great emphasis on reducing the incidence of hospital-acquired infections, including catheter-associated UTI (CAUTI). This study will evaluate the effectiveness of Betadine irrigation solution (2% povidone-iodine) instilled into the bladder immediately prior to indwelling catheter removal to decrease the risk of subsequent bacteriuria, leading to decreased rates of NHSN defined CAUTI.

COMPLETED
Variability in the Measurement of WBCT Between Blood Drawn From Indwelling Catheters and Direct Venipuncture
Description

1. Determine if there is any difference between the whole blood clotting time results obtained from blood drawn from indwelling catheters and direct venipuncture 2. Determine the intra-subject variability in both procedures

Conditions
COMPLETED
Study to Assess Duration of Indwelling Catheter After Sacrocolpopexy
Description

Objectives The objective of this study is to help identify the best practice regarding the use of indwelling catheter after minimally invasive urogynecologic surgery. Investigators propose a randomized controlled trial comparing the immediate removal of indwelling urethral catheter, after minimally invasive sacrocolpopexy, to the present standard catheter removal on post operative day one. Evidence based catheter management will be helpful to both providers and patients in post-operative decision making. Specific Aims Aim 1: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy results in shorter hospital stay than removal on postoperative day 1. Aim 2: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy confers no increased risk of re-catheterization. Aim 3: To demonstrate that immediate removal of catheter after minimally invasive sacrocolpopexy decreases the occurrence of urinary tract infection. Design A randomized controlled trial comparing the standard overnight indwelling urethral catheterization with removal of catheter immediately post surgery after minimally invasive sacrocolpopexy, at Oregon Health \& Science University. Outcome measures Primary outcome measures are hospital stay in hours after completion of surgery and need for re-catheterization. Hospital stay will be counted from the time the patient leaves the operating room to the time she leaves the hospital. To avoid confounding, investigators are only including the first / morning case of the day. For re-catheterization, investigators will evaluate if patient was able to void after completion of surgery. Investigators will compare the post voiding residuals, the need for re-catheterizations and the numbers of patients going home with an indwelling catheter between the two groups. Investigators will also compare the number of urinary tract infections, as documented by urine culture and subsequent treatment, between the two groups. Study Subjects Study subjects will be women undergoing minimally invasive sacrocolpopexy. Women will be invited to participate in the study during their preoperative visit. If they agree to participation, this will be noted in their chart. Randomization to group will occur immediately following surgery.

COMPLETED
Utility of Indwelling Catheter in Orthopaedic Patients Receiving Spinal Anesthesia
Description

A study measuring utility of indwelling bladder catheter placement in orthopaedic surgical patients receiving spinal anesthesia. Study will track clinical outcomes, patient satisfaction and cost efficacy. Absence of indwelling bladder catheter may decrease urinary tract infection (UTI) incidence, increase patient satisfaction, and decrease cost burden without increasing postoperative urinary retention (POUR) incidence.

UNKNOWN
Bladder Morphology Using 2 Different Catheter Designs
Description

Demonstrate and compare the 3D morphology of the bladder wall in full and drained states with 2 different kinds of bladder catheters in place. (Foley Catheter vs. Cystosure Catheter)

TERMINATED
Maintaining Patency in BioFlo Implanted Port Catheters With Saline Only Flushes
Description

The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in BioFlo implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.

COMPLETED
Maintaining Patency in Implanted Port Catheters
Description

The purpose of this study is to determine the safest and most effective flushing solution for maintaining patency (unobstructed flow) in implanted port catheters. The complication rate in patients whose ports are flushed with saline only will be compared to the complication rate in patients whose ports are flushed with a combination of saline and heparinized saline.

COMPLETED
RCT Foley Catheter Study for Elective TJA
Description

Urinary retention is a known complication following surgical procedures, with a theoretical increased risk in patients receiving neuraxial anesthesia due to a decreased ability to sense bladder distension. Urinary retention is associated with adverse events including bladder atony, increased post void residuals, and postoperative urinary tract infection. Treatment of urinary retention involves intermittent or indwelling urinary catheter placement, both of which are associated with an increased prevalence of postoperative urinary tract infection. There currently is no consensus whether the use of a urinary catheter in elective joint arthroplasty with neuraxial anesthesia decreases the risk of urinary retention. The prevalence of retention reported in the literature varies widely with reports anywhere from 0% to 75% in patients with early removal of a catheter or after procedures performed without a catheter. The goal of this study is to determine whether the routine use of an indwelling urinary catheter decreases the rate of postoperative urinary retention in patients undergoing elective joint arthroplasty.

COMPLETED
Optimal Duration of Indwelling Urinary Catheter Following Pelvic Surgery
Description

There is no general agreement about the optimal duration of postoperative urinary drainage, with relevant literature reporting durations ranging from 1 to 10 days. The available research supporting the routine use of prolonged catheterization is limited and studies investigating early removal following infraperitoneal colorectal surgery have largely been underpowered to form valid practice conclusions. The aim of the investigators study is to determine whether a postoperative colorectal patient can safely have an indwelling catheter removed on postoperative day one (24 hours following surgery) with the addition of a study medication (prazosin), without a statistically significant difference in the incidence of urinary retention compared to the standard, accepted approach of delayed removal (72 hours postoperatively). Patients undergoing laparoscopic and open pelvic colorectal surgery below the peritoneal reflection for both benign and malignant conditions will be randomized into two groups: group one will have the catheter removed on postoperative day 3 (72 hours postoperatively) Group 2 will have a dose of the alpha-blocker prazosin given 6 hours prior to catheter removal and will have the urinary catheter removed on postoperative day 1 (24 hours postoperatively).

RECRUITING
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Description

This study investigates whether alteplase can help to improve pleural fluid drainage and dyspnea (breathlessness) in patients with non-draining malignant pleural effusion. Alteplase helps dissolve blood clots and is used to treat heart attacks, strokes, and clots in the lungs. Alteplase may help to control symptoms of breathlessness.

RECRUITING
EXPAREL or Lidocane as Local Anesthetic in Patients Undergoing Pleuroscopy With Pleural Biopsy and Indwelling Pleural Catheter Placement
Description

This phase II trial investigates the effect of EXPAREL compared to lidocane as a local anesthetic in patients who are undergoing pleuroscopy with pleural biopsy and indwelling pleural catheter placement. This trial aims to see whether EXPAREL or lidocane is able to make patients more comfortable.

RECRUITING
Indwelling Pleural Catheters with or Without Doxycycline in Treating Patients with Malignant Pleural Effusions
Description

This study is designed to obtain preliminary data comparing indwelling pleural catheters (IPCs) versus IPCs plus doxycycline for pleurodesis as treatments for malignant pleural effusion (MPE). Indwelling pleural catheters (IPCs) are commonly used to treat pleural effusions (build-up of fluid in the lungs). Doxycycline is an antibiotic that is also used to treat pleural effusions. The goal of this clinical research study is to learn if adding doxycycline to the use of an IPC can lead to shorter treatment times with IPCs.

TERMINATED
Rapid Pleurodesis Through an Indwelling Pleural Catheter
Description

The primary objective of the study is to evaluate whether the use of a rapid pleurodesis protocol using 10% iodopovidone immediately after tunneled pleural catheter placement improves time to IPC removal compared to patients who receive an IPC alone.

TERMINATED
Indwelling Pleural Catheter With Either Doxycycline or Saline at Day 7 for Pleurodesis
Description

The goal of this clinical research study is to compare indwelling pleural catheters (IPC) in combination with saline (the current standard of care) versus IPC in combination with doxycycline as treatment for pleural effusions.

ENROLLING_BY_INVITATION
Biomarker Levels During Indwelling Pleural cAtheter Sample Testing
Description

Some patients that have a tunneled pleural catheter will not have the pleural fluid (water around the lung) return after some time (pleurodesis). The purpose of this study is to understand how the investigators can predict who will achieve pleurodesis and how this occurs by studying the pleural effusion.

TERMINATED
Study of Valproic Acid (VPA) vs Placebo to Shorten Time of Indwelling Pleural Catheter
Description

The goal of this clinical research study is to learn if receiving valproic acid (VPA) compared to a placebo can reduce the amount of time you will need to have an indwelling pleural catheter compared to the standard of care, which involves using an indwelling pleural catheter alone. VPA is designed to stop cancer cells from dividing and maturing. This may cause the cancer cells to become less malignant and cause less pleural fluid production. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Conditions
COMPLETED
Impact of Aggressive Versus Standard Drainage Regimen Using a Long Term Indwelling Pleural Catheter
Description

Purpose and Objective: The purpose of this study is to determine if the rate of spontaneous pleurodesis using the Pleurx® catheter could be increased by simply increasing the frequency of pleural drainage and, if so, whether catheter-related complications can be minimized and spare patients the need for long term management of the Pleurx® catheter.

COMPLETED
Effect of CAUTI Prevention Alert - A Randomized Control Trial
Description

This study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of CAUTIs with a large, randomized controlled trial within a three-hospital academic medical center. Hypothesis The proposed urinary-catheter removal alerts will decrease the number of catheter days and decrease the number of catheter associated urinary tract infections (CAUTIs), but will not affect the catheter re-insertion rate.