Intra-Abdominal Hypertension Clinical Trial
Official title:
The Influence of Furosemide on Fluid Balance and Intra-abdominal Pressure in Mechanically Ventilated Critically Ill Patients With Secondary Intra-abdominal Hypertension
Intra-abdominal hypertension (IAH) is a frequent cause of organ dysfunction in critically ill patients. Secondary IAH is mainly caused by excessive fluid resuscitation.The World Society for the Abdominal Compartment Syndrome (WSACS) recommends using diuretics to remove excess fluids and decrease intra-abdominal pressure (IAP). However, critically ill patients may not tolerate negative fluid balance in the acute phase of their disease and the injured kidney may not respond to diuretics. The aim of this study is to evaluate the influence of furosemide on fluid balance, IAP and kidney function in critically ill patients.
Intra-abdominal hypertension (IAH) and abdominal compartment syndrome (ACS) have been shown
to cause organ dysfunction and mortality in different populations of critically ill
patients. According to consensus definitions published by the World Society for the
Abdominal Compartment Syndrome (WSACS), secondary IAH is due to a disease process outside
the abdominal cavity. It is mainly caused by massive fluid resuscitation leading to bowel
and abdominal wall edema or increased intra-abdominal volume and decreased abdominal wall
compliance. Large observational studies have shown that positive fluid balance is an
independent risk factor for mortality. The development of secondary IAH may be one of the
mechanisms involved in this phenomenon. This has lead to the hypothesis that prognosis may
be improved by managing fluid overload and aiming for a negative fluid balance as soon as
possible after the resuscitation phase of the disease.
Several authors have shown in case reports and small series that renal replacement therapy
with ultrafiltration can be used successfully to remove excess fluid and lower
intra-abdominal pressure (IAP), but renal replacement therapy is invasive and clinicians may
be reluctant in considering this therapy in patients with preserved diuresis and kidney
function. In an effort to achieve the same goal using a less invasive technique, the new
medical management algorithm for IAH published by the WSACS recommends the use of judicious
diuresis in order to achieve a negative fluid balance and a decrease in IAP.
However, the kidney is especially sensitive to the deleterious effects of IAH and may be
unresponsive to diuretics in the presence of IAH. Also, ongoing inflammation and capillary
leak may lead to relative hypovolemia and impaired response to diuretics.
We plan a multicenter study to evaluate the influence of furosemide on fluid balance and IAP
in critically ill patients with secondary intra-abdominal hypertension and to document the
effect on the function of other organ systems. The aim of this study is to evaluate the
feasibility and the safety of the furosemide administration protocol and to provide
preliminary data to allow for an adequate power calculation.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01507766 -
The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
|
Phase 4 | |
Completed |
NCT03567265 -
Intra-abdominal Hypertension and Associated Factors Among Patients Admitted in Intensive Care Units in Uganda.
|
||
Completed |
NCT02543658 -
Neostigmine Treatment of Acute Pancreatitis Combined With Intra-abdominal Hypertension
|
Phase 2 | |
Completed |
NCT02514135 -
Intra-abdominal Hypertension in Critically Ill Patients
|
||
Recruiting |
NCT01825304 -
The Study of Using Esophageal Pressure to Guide the PEEP Setting in Abdominal Hypertension Patients Who Undergoing Mechanical Ventilation
|
Phase 4 | |
Recruiting |
NCT02944292 -
Effect of Sedation on Intra-abdominal Pressure
|
Phase 4 | |
Not yet recruiting |
NCT03670771 -
Intraabdominal Pressure in Critically Ill Patients
|
||
Not yet recruiting |
NCT03876418 -
Surveillance, Prevention and Treatment of Intra-abdominal Hypertension and Abdominal Compartment Syndrome
|
N/A | |
Not yet recruiting |
NCT04286490 -
Prone Position and Renal Resistive Index
|
N/A | |
Completed |
NCT01355094 -
Peritoneal Vacuum Therapy to Reduce Inflammatory Response From Abdominal Sepsis/Injury
|
N/A | |
Not yet recruiting |
NCT02814734 -
Abdominal Compartment Syndrome : Diagnostic and Prognostic Value of CT Findings - a Prospective Study
|
N/A | |
Recruiting |
NCT04463745 -
Organ Dysfunction Associated With Intra Abdominal Pressures in Liver Transplantation
|
||
Completed |
NCT00747552 -
Intra-Abdominal Hypertension in Neonatal Intensive Care Patients
|
N/A | |
Completed |
NCT05732545 -
Application of Enteral Nutrition Program in Patients With Intra-abdominal Hypertension Oriented by Intra-abdominal Pressure
|
N/A | |
Enrolling by invitation |
NCT05070572 -
Measuring Intraabdominal Pressure, Lactic Acid, and Urine Output
|
||
Completed |
NCT04481880 -
Correlation of Intra-abdominal Pressure With Gastric and Urinary Bladder Pressures in Patients With Morbid Obesity
|
||
Withdrawn |
NCT01077895 -
The Influence of Fluid Removal Using Continuous Venovenous Hemofiltration (CVVH) on Intra-abdominal Pressure and Kidney Function
|
Phase 3 | |
Recruiting |
NCT06333366 -
First-In-Human Study of PDT to Detect IAH
|
N/A | |
Completed |
NCT04525027 -
Predictive Ability of Intra-Abdominal Pressure for Mortality in Patients With Severe Acute Pancreatitis
|
||
Not yet recruiting |
NCT06160856 -
Correlation of Ultrasonography Indices of Venous Congestion With Intra-abdominal Pressure in ICU Patients.
|