Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
Aperçu de l'étude
Statut
Les conditions
Description détaillée
STUDY DESIGN This is the prospective interventional randomized controlled trial in which effect of protein prescription on UUN and clinical outcome of critically ill patients enroll in the study will compare The NUTRIC scores will be calculated manually, based on data from the medical records of critically ill patients.This trail will be conducted in three stages.
In Phase I all admitted patients in critical care unit will be screen by. APACHE II NUTRIC Score Phase II: Patients with nutrition risk will randomly divided into two group (1:1) Interventional Group None Interventional Group Phase III: Follow the patient for 28 days after discharge from Hospital. Study Locale The study will be conducted in the ICUs (SICUs, MICUs, HDU) of Hospital in Islamabad, for this study organizational approval from formal ethical committee will be taken during the time period of six months.
STATISTICAL METHODS:
Descriptive statistics will be use for demographic data and over all outcomes, further more analytical stat will be used to the type of variables and objective of the study. Z test will be use for the comparison of quantitative variables and Chi square test will be use for categorical data. A NOVA will be use where applicable
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Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Zainab Bibi, M.phill
- Numéro de téléphone: 03349103415
- E-mail: bibi_zainab@yahoo.com
Sauvegarde des contacts de l'étude
- Nom: Dr.Rezzan Khan, phd
- Numéro de téléphone: 03455267371
- E-mail: rezzankhan@hotmail.com
Lieux d'étude
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Federal
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Islamabad, Federal, Pakistan, 46000
- Allama Iqbal Open University
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Contact:
- Zainab Bibi, M.phill
- Numéro de téléphone: 03349103415
- E-mail: bibi_zainab@yahoo.com
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Contact:
- Mahparah Safdar, Phd
- Numéro de téléphone: 03005610162
- E-mail: mahpara.jadoon@aiou.edu.pk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Critically ill patient with nutritional risk Age >18 years Pt. ICU stay> 48hrs
Exclusion Criteria:
Patients on ventilator > 72 h < 48 hrs.' stay in ICU Withdrawal of life support within 7 days of randomization
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: 1 g per kg body weight per day
Protein will be receive by patients that is 1g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016. Base line characters(BMI, nitrogen Balance, Protein biomarker, LFTs, RFTs, GCS) |
In this study intervention will be the dose of protein, one group will be prescribed with the protein dose (1 g/kg/day) and other group will be on prescribed higher dose (2gm/kg/day) of protein according to the ASPEN guideline for critically ill and the energy requirements (other than proteins) will be 25 kcal/kg of adjusted body weight (Picolo et al.,).
Each subject in the trail will provide remaining medical nutrition therapy according to the therapeutic guidelines in the field.
The medical nutrition management other than protein will be adjust according to need of each patient.
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Comparateur actif: 2 g per kg body weight per day
Protein will be receive by patients that is 2g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016. Base line characters(BMI, nitrogen Balance, Protein bio marker, LFTs. , RFTs, GCS) |
In this study intervention will be the dose of protein, one group will be prescribed with the protein dose (1 g/kg/day) and other group will be on prescribed higher dose (2gm/kg/day) of protein according to the ASPEN guideline for critically ill and the energy requirements (other than proteins) will be 25 kcal/kg of adjusted body weight (Picolo et al.,).
Each subject in the trail will provide remaining medical nutrition therapy according to the therapeutic guidelines in the field.
The medical nutrition management other than protein will be adjust according to need of each patient.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in nitrogen balance
Délai: for base line is within 24hours og randomization,for nitrogen balence reassessment every 72 hourly
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change in nitrogen balance from baseline.
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for base line is within 24hours og randomization,for nitrogen balence reassessment every 72 hourly
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Readmission in hospital within 30 days of discharge.
Délai: 30 days after discharg
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Patient will be followed for 30 days after discharge from hospital for monitoring, e.g.
readmission in hospital Mortality ratio
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30 days after discharg
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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SOFA Score,
Délai: 72hrly till ICU saty
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this tool will be use to track a person's status during the stay in an critical care unit (ICU) to determine the extent of a person's organ function or rate of failure.
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72hrly till ICU saty
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protein bio markers
Délai: 72hrly till ICU saty
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Blood Urea Nitrogen, Albumin, C- reactive protien
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72hrly till ICU saty
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Dr. Mahpara Safdar, phd, Allama Iqbal Open University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HEC acadmic research
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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