Constipation Clinical Trial
Official title:
Impact of Laxative Therapy With Lactulose in the Evolution of Organ Dysfunction in Critically Ill Patients.
MAIN FEATURES OF THE STUDY: therapeutic intervention. Constipation is a frequent
complication in critical ill patients. The disaccharide lactulose has a laxative osmotic
activity. Given the scant evidence and the potential risk associated with constipation in
seriously ill patients, this study aims to assess the impact of laxative therapy in the
prognosis of critically ill patients.
Study hypothesis: Constipation is part of the clinical spectrum of intestinal dysfunction
and if treated can result in improved prognosis for critically ill patients.
OBJECTIVES: Evaluate the impact of daily laxative therapy in the prognosis of critically ill
patients through the evaluation of organ failure by the sequential organ failure score
assessment (SOFA). Will also be evaluated morbidity data, namely incidence of bloodstream
infection, pneumonia and severe sepsis, days free of mechanical ventilation, length of
hospital stay, ICU and hospital mortality.
The study will be conducted in two intensive care units of Hospital Sao Paulo, UNIFESP.
Inclusion criteria: patients who are mechanically ventilated, with prediction to stay in the
ICU for more than three days and getting at least 20% of full nutritional support in the
form of enteral nutrition. Patients will be randomized into two groups: Group 1 - patients
treated according to medical prescription. Group 2 - patients will receive lactulone in
order to evacuate daily. The patient included in the intervention group will receive
latulose 30 ml of 8 in 8 hours. Patients will be monitored, adjusted doses and procedures,
if necessary. It is intended to include 44 patients per group.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
| Recruiting |
NCT06292949 -
Clinical Study of Resistant Starch in Improving Constipation
|
N/A | |
| Recruiting |
NCT04132661 -
MRI Assessment of Mode of Action of Bisacodyl, Single Dose
|
Phase 4 | |
| Recruiting |
NCT05734833 -
Do Probiotics Improve Recovery From Acute Constipation in Kids?
|
N/A | |
| Terminated |
NCT02839889 -
Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)
|
Phase 4 | |
| Completed |
NCT02726295 -
The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
|
Phase 4 | |
| Recruiting |
NCT02255747 -
Anal Dilatation for Infants and Children With Constipation
|
N/A | |
| Completed |
NCT02246647 -
Biomarkers for Intestinal Permeability in Patients With Constipation
|
||
| Completed |
NCT01566409 -
Maintenance Treatment for Children With Constipation
|
N/A | |
| Completed |
NCT01710579 -
Normal Values in Ano-rectal 3D High Resolution Manometry
|
N/A | |
| Completed |
NCT02863848 -
Effect of Inulin-type Fructans on Constipated Children.
|
N/A | |
| Completed |
NCT02658201 -
Ultrafast MRI Imaging to Exclude Constipation
|
N/A | |
| Completed |
NCT01695915 -
Diurnal Variation in Rectal Diameter
|
N/A | |
| Completed |
NCT01438567 -
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
|
Phase 3 | |
| Completed |
NCT01411501 -
Efficacy and Safety of Acupuncture for Functional Constipation
|
Phase 3 | |
| Completed |
NCT01474499 -
A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation
|
Phase 3 | |
| Completed |
NCT01170039 -
The Effectiveness of Lubiprostone in Constipated Diabetics
|
Phase 4 | |
| Completed |
NCT00931853 -
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
|
Phase 3 | |
| Active, not recruiting |
NCT02442115 -
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
|
||
| Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 |