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Effect of Supplementation of a Protein specific to body composition in the vein and observation of blood values and mortality in ICU patients after abdominal surgery

Effect of early parenteral alaninaglutamine dipeptide complementation on inflammatory markers and prognostic indexes in critically ill patients after major abdominal surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-4jx82p
Enrollment
Unknown
Registered
2020-01-15
Start date
2017-06-09
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nutritional and metabolic diseases

Interventions

After randomization, data will be collected from participants before and after the intervention, such as: demographic, anthropometric data, prognostic indexes, diagnoses, hematological and biochemical
Other
G07.203.300.456

Sponsors

Eliseuda Marinho da Silva
Lead Sponsor
Hospital Universitário Lauro Wanderley
Collaborator

Eligibility

Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Ages 18-90 years; after major abdominal surgery in ICU; contraindication or failure of enteral nutrition within 48 hours; use of parenteral nutrition for at least 7 days; no history of kidney or liver disease

Exclusion criteria

Exclusion criteria: Life expectancy greater than 7 days, ie palliative care; unstable hemodynamic state; chronic renal failure where dialysis is insufficient; previous history of severe 24-hour sepsis; liver failure with hepatic encephalopathy or portal hypertension; pre-existing endocrine disorders; continuous 24-hour propofol infusion; chronic maintenance of systemic steroid therapy; immunocompromise; pregnancy or lactation; severe brain injury; seizure disorder with anticonvulsant medication; metastatic cancer of lymphoma four; psychiatric history; family members unable to understand the nature and scope of the study

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: Improvement of the inflammatory process is expected by supplementation of parenteral alanilglutamine dipeptide in critically ill patients following major abdominal surgery using laboratory examination (hematological and biochemical). Blood aliquots will be collected by qualified technicians from Lauro Wanderley University Hospital, packed in appropriate packaging and sent to the hospital's own laboratory, where they will follow the routine of methods, specific parameters: blood count determinations will be by flow cytometry by the Sysmex® XN analyzer. 1000 and the biochemical determinations performed by the Architec® C 8000 automated analyzer. The methods employed for lactic dehydrogenase will be lactatopyruvate (NADH) - UV optimized, urease urea, creatinine by Jaffé-Picrate alkaline, creatinine clearance by estimation of the Cockcroft-formula. Gault, ASL and AST by NADH (without pyridoxalphosphate), Alpha-phosphate by paranitrophenyl phosphate, GGT by modified Szasz, Total and direct bilirubin with dichlorophenyldiazonium salt, indirect bilirubin by calculating total bilirubin - direct total bilirubin cholesterol oxidase, HDL-C by homogeneous protein, LDL-C by Friedewald's formula, VLDL-C by calculation of total cholesterol - HDL-C and LDL-C, agglutination triglyceride, glucose by hexokinase, total proteins by biuride, bromocresol green albumin, calculus from Total protein and albumin, PCR and AGPA will be by agglutination of the serum sample via immunoturbidimetry. All observed at the beginning and after the intervention, always comparing with the control group. We will adopt a significance level of 5% to reject the null hypothesis.;Expected Outcome 2: Reduction in mortality from parenteral L alanyl Lglutamine supplementation in critically ill patients following major abdominal surgery is expected using the prognostic index for organ dysfunction, the Sequential Organ Failure Assessment (SOFA) recommended for patients. in intensive care units, w

Secondary

MeasureTime frame
Expected Outcome 1: A reduction in ICU and hospital stay (days) is expected in patients with supplementation of parenteral alanil glutamine dipeptide after major abdominal surgery using follow-up of the patient's hospitalization after intervention and comparing with the control group. We will adopt a significance level of 5% to reject the null hypothesis

Countries

Brazil

Contacts

Public ContactEliseuda Silva

Hospital Universitário Lauro Wanderley

eliseudamarinho1@gmail.com55 083 3216-7964 / 3216-7955

Outcome results

None listed

Source: REBEC (via WHO ICTRP)