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High Protein Intake and Early Exercise in Adult Intensive Care Patients

Primary Purpose

Critically Ill Patients

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High protein nutrition
Cycle ergometry exercise
Usual care group
Sponsored by
Hospital Sao Domingos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critically Ill Patients focused on measuring Protein, exercise, critical illness, outcome,

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

We will include 180 consecutive patients admitted to one of the study ICUs

  • Aged 18 years or above.
  • Non-pregnant.
  • Requiring mechanical ventilation for at least 48 hours.
  • Expected ICU stay higher than 3 days.

Exclusion Criteria:

  • Inability to walk without assistance before the acute illness that led to ICU admission (use of gait aid is not an exclusion criterion).
  • Cognitive impairment prior to hospitalization described by relatives and evaluated by the ICU psychology team.
  • Neuromuscular diseases that compromise weaning from mechanical ventilation.
  • Acute pelvic fracture.
  • Unstable spinal cord trauma.
  • Patients considered moribund.
  • In some situations patients will not be included in the resistive exercise program for as long as a temporary limiting factor remains:
  • Patients undergoing neuromuscular blocking drugs.
  • Patients under high-dose vasoactive drug use.
  • Mechanical ventilation with FIO2 (fraction of inspired oxygen) ≥ 60% and / or PEEP (positive end-expiratory pressure)> 12 cm H2O.
  • Intracranial hypertension.
  • . Open abdomen.
  • Status epilepticus.

Sites / Locations

  • Icu Hospital Sao Domingos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

High protein and exercise (HPE) group

Usual care group

Arm Description

Begining within 48 hours of ICU admission participants will receive nutrition support with energy expenditure measured by indirect calorimetry, 2.0 to 2.2 g/kg/day of protein and in-bed cycle ergometry exercise.

Participants randomized to the usual care group will receive usual care protein and exercise

Outcomes

Primary Outcome Measures

Physical component summary (PCS) 3 months after randomization
Blind assessment of PCS after 3 months after randomization
Physical component summary (PCS) 6 months after randomization
Blind assessment of PCS after 6 months after randomization

Secondary Outcome Measures

handgrip strength
handgrip strength measured at ICU discharge,
Duration of mechanical ventilation
Length of time under mechanical ventilation
Length of ICU stay
Length of ICU stay
Hospital mortality
Hospital mortality

Full Information

First Posted
March 11, 2018
Last Updated
July 24, 2021
Sponsor
Hospital Sao Domingos
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1. Study Identification

Unique Protocol Identification Number
NCT03469882
Brief Title
High Protein Intake and Early Exercise in Adult Intensive Care Patients
Official Title
High Protein Intake and Early Exercise in Adult Intensive Care Patients: Impact on Functional Outcomes. A Randomized Controlled Phase II Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Sao Domingos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study analyse the impact of high protein intake associated to early programed exercise on functional outcomes of adult intensive care patients.
Detailed Description
The muscle weakness associated to intensive care, one of the components of Post Intensive Care Syndrome (PICS) has a significant impact on the short-term and long-term outcomes in the critically ill patient (1, 2). Puthucheary et al. (3) analyzed 63 septic patients with imaging examination and established a clear relationship between the number of organ failures and muscle loss in the first 10 days of ICU. Although a study involving 244 critically ill patients has shown an alarming relationship between reduced muscle mass at admission and mortality (4), evidences that nutritional interventions can attenuate muscle loss and result in improvement in outcome are unclear. Recent studies evaluating the impact of nutritional therapy on clinical outcomes have surprisingly demonstrated that patients who received full nutritional intake did not differ in outcomes when compared to those receiving reduced nutritional intake, the so-called permissive underfeeding (5, 6, 7). Careful analysis of these studies, however, reveals that the authors define hyponutrition as synonymous with reduced calorie intake, without mentioning the protein intake offered to the patients. The study with the greatest scientific repercussion (8) used reduced caloric intake in the study group, but the protein intake did not differ between groups. Observational studies comparing high protein intake with conventional intake have shown improvement in outcome indicators in patients receiving more than 1.6 and even more than 2.0 g / kg / day of protein (9, 10). Recently the intensive care medicine research agenda published in the journal of the European Society of Intensive Care Medicine, the top priority of the nutrition research in the critically ill patients was to compare normal and hyperproteic nutrition ideally associated with physical activity (11). Several recent studies have shown benefits of early physical rehabilitation in the critically ill patient (12, 13). The optimal integration between adequate protein intake and exercise in the critically ill patient may have an impact on short- and long-term outcomes, but this hypothesis has not yet been tested by studies with a good methodology. The hypothesis of this prospective randomized phase II study is that the association of high protein intake with early physical rehabilitation improves physical function after hospital discharge with a significant impact on quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critically Ill Patients
Keywords
Protein, exercise, critical illness, outcome,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
Blinded outcomes assessment
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High protein and exercise (HPE) group
Arm Type
Experimental
Arm Description
Begining within 48 hours of ICU admission participants will receive nutrition support with energy expenditure measured by indirect calorimetry, 2.0 to 2.2 g/kg/day of protein and in-bed cycle ergometry exercise.
Arm Title
Usual care group
Arm Type
Other
Arm Description
Participants randomized to the usual care group will receive usual care protein and exercise
Intervention Type
Dietary Supplement
Intervention Name(s)
High protein nutrition
Intervention Description
Patients in the HPE group will be submitted to nutritional support preferably through the enteral route. Energy expenditure will be determined by indirect calorimetry. They will receive 2.0 to 2.2 grams/kg/day of protein.
Intervention Type
Device
Intervention Name(s)
Cycle ergometry exercise
Intervention Description
Patients will be submitted to two daily sessions of exercise (cycle ergometry) 15 minutes duration each, during the 7 days of the week. The intervention will be maintained exclusively duting the patient's stay in the ICU. The cycle ergometer will be the MotoMed Letto II (Reck Technik, Germany).
Intervention Type
Other
Intervention Name(s)
Usual care group
Other Intervention Name(s)
No intervention
Intervention Description
Participants randomized to the usual care group will receive usual care protein and exercise.
Primary Outcome Measure Information:
Title
Physical component summary (PCS) 3 months after randomization
Description
Blind assessment of PCS after 3 months after randomization
Time Frame
3 months after randomization
Title
Physical component summary (PCS) 6 months after randomization
Description
Blind assessment of PCS after 6 months after randomization
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
handgrip strength
Description
handgrip strength measured at ICU discharge,
Time Frame
20 days
Title
Duration of mechanical ventilation
Description
Length of time under mechanical ventilation
Time Frame
20 days
Title
Length of ICU stay
Description
Length of ICU stay
Time Frame
20 days
Title
Hospital mortality
Description
Hospital mortality
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: We will include 180 consecutive patients admitted to one of the study ICUs Aged 18 years or above. Non-pregnant. Requiring mechanical ventilation for at least 48 hours. Expected ICU stay higher than 3 days. Exclusion Criteria: Inability to walk without assistance before the acute illness that led to ICU admission (use of gait aid is not an exclusion criterion). Cognitive impairment prior to hospitalization described by relatives and evaluated by the ICU psychology team. Neuromuscular diseases that compromise weaning from mechanical ventilation. Acute pelvic fracture. Unstable spinal cord trauma. Patients considered moribund. In some situations patients will not be included in the resistive exercise program for as long as a temporary limiting factor remains: Patients undergoing neuromuscular blocking drugs. Patients under high-dose vasoactive drug use. Mechanical ventilation with FIO2 (fraction of inspired oxygen) ≥ 60% and / or PEEP (positive end-expiratory pressure)> 12 cm H2O. Intracranial hypertension. . Open abdomen. Status epilepticus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WIDLANI s MONTENEGRO, RN, Ms
Organizational Affiliation
Hospital Sao Domingos
Official's Role
Study Director
Facility Information:
Facility Name
Icu Hospital Sao Domingos
City
Sao Luis
State/Province
Maranhão
ZIP/Postal Code
65060-645
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24758618
Citation
Kress JP, Hall JB. ICU-acquired weakness and recovery from critical illness. N Engl J Med. 2014 Apr 24;370(17):1626-35. doi: 10.1056/NEJMra1209390. No abstract available.
Results Reference
background
PubMed Identifier
24247473
Citation
Fan E, Dowdy DW, Colantuoni E, Mendez-Tellez PA, Sevransky JE, Shanholtz C, Himmelfarb CR, Desai SV, Ciesla N, Herridge MS, Pronovost PJ, Needham DM. Physical complications in acute lung injury survivors: a two-year longitudinal prospective study. Crit Care Med. 2014 Apr;42(4):849-59. doi: 10.1097/CCM.0000000000000040.
Results Reference
background
PubMed Identifier
24108501
Citation
Puthucheary ZA, Rawal J, McPhail M, Connolly B, Ratnayake G, Chan P, Hopkinson NS, Phadke R, Dew T, Sidhu PS, Velloso C, Seymour J, Agley CC, Selby A, Limb M, Edwards LM, Smith K, Rowlerson A, Rennie MJ, Moxham J, Harridge SD, Hart N, Montgomery HE. Acute skeletal muscle wasting in critical illness. JAMA. 2013 Oct 16;310(15):1591-600. doi: 10.1001/jama.2013.278481. Erratum In: JAMA. 2014 Feb 12;311(6):625. Padhke, Rahul [corrected to Phadke, Rahul].
Results Reference
background
PubMed Identifier
24825371
Citation
Hermans G, Van Mechelen H, Clerckx B, Vanhullebusch T, Mesotten D, Wilmer A, Casaer MP, Meersseman P, Debaveye Y, Van Cromphaut S, Wouters PJ, Gosselink R, Van den Berghe G. Acute outcomes and 1-year mortality of intensive care unit-acquired weakness. A cohort study and propensity-matched analysis. Am J Respir Crit Care Med. 2014 Aug 15;190(4):410-20. doi: 10.1164/rccm.201312-2257OC.
Results Reference
background
PubMed Identifier
22307571
Citation
National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Rice TW, Wheeler AP, Thompson BT, Steingrub J, Hite RD, Moss M, Morris A, Dong N, Rock P. Initial trophic vs full enteral feeding in patients with acute lung injury: the EDEN randomized trial. JAMA. 2012 Feb 22;307(8):795-803. doi: 10.1001/jama.2012.137. Epub 2012 Feb 5.
Results Reference
background
PubMed Identifier
23689848
Citation
Doig GS, Simpson F, Sweetman EA, Finfer SR, Cooper DJ, Heighes PT, Davies AR, O'Leary M, Solano T, Peake S; Early PN Investigators of the ANZICS Clinical Trials Group. Early parenteral nutrition in critically ill patients with short-term relative contraindications to early enteral nutrition: a randomized controlled trial. JAMA. 2013 May 22;309(20):2130-8. doi: 10.1001/jama.2013.5124.
Results Reference
background
PubMed Identifier
25271389
Citation
Harvey SE, Parrott F, Harrison DA, Bear DE, Segaran E, Beale R, Bellingan G, Leonard R, Mythen MG, Rowan KM; CALORIES Trial Investigators. Trial of the route of early nutritional support in critically ill adults. N Engl J Med. 2014 Oct 30;371(18):1673-84. doi: 10.1056/NEJMoa1409860. Epub 2014 Oct 1.
Results Reference
background
PubMed Identifier
25992505
Citation
Arabi YM, Aldawood AS, Haddad SH, Al-Dorzi HM, Tamim HM, Jones G, Mehta S, McIntyre L, Solaiman O, Sakkijha MH, Sadat M, Afesh L; PermiT Trial Group. Permissive Underfeeding or Standard Enteral Feeding in Critically Ill Adults. N Engl J Med. 2015 Jun 18;372(25):2398-408. doi: 10.1056/NEJMoa1502826. Epub 2015 May 20. Erratum In: N Engl J Med. 2015 Sep 24;373(13):1281.
Results Reference
background
PubMed Identifier
22209678
Citation
Allingstrup MJ, Esmailzadeh N, Wilkens Knudsen A, Espersen K, Hartvig Jensen T, Wiis J, Perner A, Kondrup J. Provision of protein and energy in relation to measured requirements in intensive care patients. Clin Nutr. 2012 Aug;31(4):462-8. doi: 10.1016/j.clnu.2011.12.006. Epub 2011 Dec 29.
Results Reference
background
PubMed Identifier
25900319
Citation
Nicolo M, Heyland DK, Chittams J, Sammarco T, Compher C. Clinical Outcomes Related to Protein Delivery in a Critically Ill Population: A Multicenter, Multinational Observation Study. JPEN J Parenter Enteral Nutr. 2016 Jan;40(1):45-51. doi: 10.1177/0148607115583675. Epub 2015 Apr 21.
Results Reference
background
PubMed Identifier
28374096
Citation
Arabi YM, Casaer MP, Chapman M, Heyland DK, Ichai C, Marik PE, Martindale RG, McClave SA, Preiser JC, Reignier J, Rice TW, Van den Berghe G, van Zanten ARH, Weijs PJM. The intensive care medicine research agenda in nutrition and metabolism. Intensive Care Med. 2017 Sep;43(9):1239-1256. doi: 10.1007/s00134-017-4711-6. Epub 2017 Apr 3.
Results Reference
background
PubMed Identifier
19623052
Citation
Burtin C, Clerckx B, Robbeets C, Ferdinande P, Langer D, Troosters T, Hermans G, Decramer M, Gosselink R. Early exercise in critically ill patients enhances short-term functional recovery. Crit Care Med. 2009 Sep;37(9):2499-505. doi: 10.1097/CCM.0b013e3181a38937.
Results Reference
background
PubMed Identifier
28181920
Citation
Gruther W, Pieber K, Steiner I, Hein C, Hiesmayr JM, Paternostro-Sluga T. Can Early Rehabilitation on the General Ward After an Intensive Care Unit Stay Reduce Hospital Length of Stay in Survivors of Critical Illness?: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2017 Sep;96(9):607-615. doi: 10.1097/PHM.0000000000000718.
Results Reference
background
PubMed Identifier
9014540
Citation
Chrispin PS, Scotton H, Rogers J, Lloyd D, Ridley SA. Short Form 36 in the intensive care unit: assessment of acceptability, reliability and validity of the questionnaire. Anaesthesia. 1997 Jan;52(1):15-23. doi: 10.1111/j.1365-2044.1997.015-az014.x.
Results Reference
background
Citation
Ciconelli RM, Ferraz MB, Santos W, Meirão 1, Quaresma MR. Brazilian-portuguese version of the SF-36. A reliable and valid quality of life outcome measure. Rev Bras Reumatologia. 1999; 39 (3): 143-50.
Results Reference
background
PubMed Identifier
34773985
Citation
de Azevedo JRA, Lima HCM, Frota PHDB, Nogueira IROM, de Souza SC, Fernandes EAA, Cruz AM. High-protein intake and early exercise in adult intensive care patients: a prospective, randomized controlled trial to evaluate the impact on functional outcomes. BMC Anesthesiol. 2021 Nov 13;21(1):283. doi: 10.1186/s12871-021-01492-6.
Results Reference
derived

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High Protein Intake and Early Exercise in Adult Intensive Care Patients

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