Prescribed hypocaloric nutrition support for critically‐ill adults

Mario I Perman; Agustín Ciapponi; Juan VA Franco; Cecilia Loudet; Adriana Crivelli; Virginia Garrote; Gastón Perman

doi:10.1002/14651858.CD007867.pub2

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Figure 1

Updated study flow diagram, 20 June 2017

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias domain presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias domain for each included study. Red colour represents high risk of bias; green, low risk of bias; and yellow, unclear risk of bias.

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Figure 4

Funnel plot of comparison: 1 Hypocaloric nutrition (intervention) vs. Control, outcome: 1.1 Mortality in hospital.

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Analysis 1.1

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 1 Mortality in hospital.

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Analysis 1.2

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 2 Mortality in ICU.

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Analysis 1.3

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 3 Mortality at 30 days.

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Analysis 1.4

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 4 Length of Hospital stay (days).

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Analysis 1.5

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 5 Length of ICU stay (days).

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Analysis 1.6

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 6 Infectious complications.

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Analysis 1.7

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 7 Length of mechanical ventilation (days).

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Analysis 1.8

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 8 Non‐infectious complications (diarrhoea).

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Analysis 1.9

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 9 Hyperglycaemia.

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Analysis 1.10

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 10 Hypoglicaemia.

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Analysis 1.11

Comparison 1 Hypocaloric nutrition (intervention) vs. Control, Outcome 11 Nitrogen balance (g/day).

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Summary of findings for the main comparison. Hypocaloric nutrition compared to control for critically‐ill adults

Hypocaloric nutrition compared to control for critically‐ill adults
Patient or population: critically‐ill adults Settings: Hospitals (intensive care units), eight in USA, two in Colombia, one in Saudi Arabia and Canada, and one each in Saudi Arabia, Germany, Greece and Iran Intervention: hypocaloric nutrition Comparison: control nutritional support with a higher caloric intake than the 'intervention' group
Outcomes	Effect estimate (range of results of individual studies)	N of Participants (studies)	Quality of the evidence (GRADE)
Mortality in hospital: death occurring during the hospital stay	Range of risk ratios from 0.23 to 5.54^a	1775 (9 studies)	⊕⊕⊝⊝ very low^b,c,d
Mortality in ICU: death occurred during the ICU stay	Range of risk ratios from 0.81 to 5.54^a	1291 (4 studies)	⊕⊕⊝⊝ very low^b,c,d
Mortality at 30 days: 28 to 30 days all‐cause mortality	Range of risk ratios from 0.79 to 3.00^a	2611 (7 studies)	⊕⊕⊝⊝ very low^b,c,d
Length of hospital stay: days stayed in the hospital	Range of length of hospital stay from 15.70 days lower to 10.70 days higher^a	1677 (10 studies)	⊕⊝⊝⊝ very low^b,c,e
Length of ICU stay: days stayed in the ICU	Range of length of ICU stay from 11.00 days lower to 5.40 days higher^a	2942 (11 studies)	⊕⊝⊝⊝ very low^b,c,e
Infectious complications: events of any type of infectious complications occurred during the hospital stay, registered by the study authors according to their diagnostic criteria of infections.	Range of risk ratios from 0.54 to 2.54^a	2804 (10 studies)	⊕⊝⊝⊝ very low^b,c,e
Length of mechanical ventilation: days on mechanical ventilation during ICU stay	Range of mean differences: 13.20 days lower to 8.36 days higher^a	3000 (12 studies)	⊕⊝⊝⊝ very low^b,c,e
GRADE Working Group grades of evidence High quality: further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: we are very uncertain about the estimate.
^aResults were not combined due to clinical heterogeneity. ^bDowngraded one level due to risk of bias: most studies had unclear or high risk of bias. ^cDowngraded one level due to imprecision issues: very wide confidence intervals. ^dDowngraded one level due to inconsistency: wide variance of point estimates across studies. ^eDowngraded one level due to inconsistency: high statistical heterogeneity I² > 50%.

Summary of findings for the main comparison. Hypocaloric nutrition compared to control for critically‐ill adults

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Table 1. Differences in participants, interventions and outcomes across included studies

Study ID	Type of participants Primary outcomes	Arm	Number of ICU participants	APACHE II score mean ± SD	Route (enteral or parenteral)	Duration of PN or EN (days)	Mechanical ventilation (% of participants)	ICU mortality %	Hospital mortality %
Ahrens 2005	Surgical participants with PN requirement Incidence/severity hyperglycaemia and insulin received by the participants	Hypoc.	8 (other 12 non‐ICU)	20 ± 9	Parenteral	6 (4 to 10)	100	Not reported	Not reported
		Control	10 (other 10 non‐ICU)	19 ± 11		7 (5 to 10)	80
Arabi 2011	Medical (mainly) and surgical participants with EN. 2 x 2 factorial trial with Intensive Insuline therapy 28 days all‐cause mortality	Hypoc.	120	25 ± 8	Enteral	Not reported	99	18	30
		Control	120	25 ± 8			99	22	43
Arabi 2015	Critically‐ill participants (75% medical) 90‐day all‐cause mortality	Hypoc.	448	21 ± 7.9	Enteral	9.1 ± 4.6	97.3	16.1	24.2
		Control	446	21 ± 8.2		9.4 ± 4.4	96.2	19.1	27.6
Battistella 1997	Trauma participants with PN requirement Length of hospital stay, length of stay in the ICU, number of days on mechanical ventilation and infectious complications.	Hypoc.	27	22 ± 5	Parenteral	10	Not reported	7.4	Not reported
		Control	30	23 ± 6		10		0
Charles 2014	Critically‐ill surgical participants Hospital‐acquired infection	Hypoc.	41	16.6 ± 0.9	Enteral & parenteral	12.6 ± 2.8	68	N/A	7.3
		Control	42	17.3 ± 0.8		10.4 ± 1.1	57	N/A	9.5
Choban 1997	Obese participants with PN requirement. Predominantly surgical diseases Achievement of nitrogen balance	Hypoc.	6 (other 10 non‐ICU)	13 ± 5	Parenteral	10 ± 3	Not reported	Not reported	0
		Control	7 (other 7 non‐ICU)	15 ± 5		11 ± 2			28.6
Ibrahim 2002	Medical ICU participants with EN Incidence of ventilator‐associated pneumonia	Hypoc.	75	26 ± 8	Enteral	5 ± 6	100	Not reported	27
		Control	75	25 ± 8		10 ± 12	100		20
McCowen 2000	Participants with predominantly surgical diseases requiring PN Glycaemic control and Infections	Hypoc.	21	not reported	Parenteral	≥ 5	50	10	Not reported
		Control	19	not reported		≥ 5	33	16
NHLBI 2012	Acute lung injury predominantly due to medical diseases (61% and 63% of participants) with EN Ventilator‐free days at study day 28	Hypoc.	508	APACHE III 92 ± 28	Enteral	6	100	Not reported	22.4
		Control	492	APACHE III 90 ± 27	Enteral	6	100		19.6
Norouzy 2013	Critically‐ill head trauma participants 28 days of all‐cause mortality	Hypoc.	30	Not reported	Enteral	7	Not reported	Not reported	10.7^a
		Control	30			7			3.8^a
Petros 2016	Medical ICU with EN and/or PN requirement Glycaemic control and mortality	Hypoc.	46	31 ± 9	Enteral & parenteral	7	not reported	22	37
		Control	54	28 ± 8		7		22	31
Rice 2011	Acute lung injury, predominantly due to medical diseases with EN Ventilator‐free days at study day 28	Hypoc.	98	27 ± 8	Enteral	6 ± 4	100	Not reported	22
		Control	102	27 ± 7		5 ± 3	100		20
Rugeles 2013	Medical ICU participants with EN requirement Change in SOFA score at 48 hours	Hypoc.	40	14 ± 5	Enteral	7	Not reported	Not reported	Not reported
		Control	40	15 ± 6
Rugeles 2016	Medical ICU participants with EN requirement Change in SOFA score at 48 hours	Hypoc.	60	13.5 ± 6.4	Enteral	7	Not reported	Not reported	30^a
		Control	60	13.7 ± 6.8					27^a
Theodorakopoulou 2016	Septic, mechanically ventilated critically‐ill participants 28‐day mortality	Hypocal.	Total sample of 74 participants	Total sample 22 ± 4	Enteral	Not reported	Not reported	Not reported	Not reported
		Control
^a28‐day mortality. EN = Enteral nutrition; ICU = Intensive Care Unit; N/A: not available; PN = Parenteral nutrition; SOFA = Sequential Organ Failure Assessment

Table 1. Differences in participants, interventions and outcomes across included studies

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Table 2. Calories and protein received in both study groups

Studies	How data was reported	Hypocaloric (intervention) group	Control group	Calories received by the "hypocaloric" intervention group (kcal/kg/day)	Calories received by the "normocaloric" control group (kcal/kg/day)	Categories denominated by the calories really received in the intervention and the control groups ^a
Ahrens 2005	Total calories/kg/day (median (IQ))^b	26.6 (26.2 to 27.5)	37 (36.0 to 38.4)	26.60 (median)	37.00 (median)	Normocaloric vs hypercaloric
	Protein g/kg/day (mean± SD)	1.61 ± 0.13	1.53 ± 0.26
Arabi 2011	Calories/day (mean ± SD)	1066.6 ± 306.1	1251.7 ± 432.5	13.85	16.40	Hypocaloric vs hypocaloric
	Protein g/day (mean ± SD)	47.5 ± 21.2	43.6 ± 18.9
Arabi 2015	Calories/day (mean ± SD)	835 ± 297	1299 ± 2470	10.56	16.04	Hypocaloric vs hypocaloric
	Protein g/day (mean ± SD)	57 ± 24	59 ± 25
Battistella 1997	Calories/kg ideal body weight/day (mean ± SD)	27.4 ± 2	34.4 ± 2	27.4 (of ideal body weight)	34.4 (of ideal body weight)	Normocaloric vs. normocaloric
	Protein g/kg ideal body weight/day (mean± SD)	1.6 ± 0.1	1.6 ± 0.2
Charles 2014	Calories/kg/day (mean ± SD)	12.3 ± 0.7	17.1 ± 1.1	12	17	Hypocaloric vs hypocaloric
	Protein g/kg/day (mean ± SD)	1.1 ± 0.1	1.1 ± 0.1
Choban 1997	Kcal/kg actual body weight/day (mean ± SD) Kcal/kg ideal body weight/day (mean ± SD)	8.6 ± 2.39 13.88 ± 2.87	17.45 ± 4.06 27.99 ± 3.83	14.00 (of ideal body weight)	28.00 (of ideal body weight)	Hypocaloric vs normocaloric
	Protein g/kg actual body weight/day (mean ± SD) Protein g/kg ideal body weight/day (mean ± SD)	1.2 ± 0.2 2.0 ± 0.1	1.2 ± 1.2 2.0 ± 0.1
Ibrahim 2002	Calories/day (mean ± SD)	126 ± 115	474 ± 400	1.53	5.81	Very hypocaloric vs very hypocaloric
	Proteins g/day (mean) (mean ± SD)	5.3 ± 5.3	18.7 ± 15.4
McCowen 2000	Calories/kg/day (mean ± SD)	14 ± 3	18 ± 4	14.30	18.40	Hypocaloric vs hypocaloric
	Proteins g/kg/day (mean ± SD)	1.1 ± 0.2	1.3 ± 0.2
NHLBI 2012	Calories/day (mean ± SD)	399 ± 225	1365 ± 596	4.64 (estimated by kcal/day divided by weight from the baseline table)	15.69 (estimated by kcal/day divided by weight from the baseline table)	Very hypocaloric vs hypocaloric
	Proteins: information not collected	‐	‐
Norouzy 2013	Calories/kg/day (mean ± SD)	Not reported	Not reported	N/A	N/A	N/A
	Protein g/kg/day (mean ± SD)	Not reported	Not reported
Petros 2016	Calories/kg/day (mean ± SD)	11.3 ± 3.1	19.7 ± 5.7	11.30	19.70	Hypocaloric vs hypocaloric
	Protein	Data not reported	Data not reported
Rice 2011	Calories/day (mean ± SD of study days 1 to 5)	300 ± 149	1418 ± 686	3.60	17.31	Very hypocaloric vs hypocaloric
	Proteins g/day (mean ± SD of study days 1 to 5)	10.9 ± 6.8	54.4 ± 33.2
Rugeles 2013	Calories/kg/day (mean ± SD)	12 ± 3.9	14 ± 6.2	12.00	14.00	Hypocaloric vs hypocaloric
	Protein g/kg/day (mean ± SD)	1.4 ± 0.44	0.76 ± 0.32
Rugeles 2016	Total calories/kg ideal body weight/day (mean ± SD)	12.6 ± 3.4	20.5 ± 5.1	13	21	Hypocaloric vs hypocaloric
	Protein g/kgIBW/day (mean ± SD)	1.4 ± 0.4	1.4 ± 0.3
Theodorakopoulou 2016	Calories/day (mean ± SD)	962 ± 314	1308 ± 513	Not reported Estimated^c 16.63 kcal/kg/day	Not reported Estimated^c 22.62 kcal/kg/day	Estimated^c Hypocaloric vs normocaloric
	Protein g/day (mean ± SD)	57 ± 24	59 ± 25	Not reported Estimated^c 0.99 g/kg/day	Not reported Estimated^c 1.02 g/kg/day
^aCategories denominated by the amount of calories really received by both study groups, according to the following: very hypocaloric = < 10 kcal/kg/day; hypocaloric = ≥ 10 to < 25 kcal/kg/day; normocaloric = ≥ 25 to < 35 kcal/kg/day; hypercaloric = ≥ 35 kcal/kg/day. ^bIQ: interquartile range ‐ Median total calories received by all 20 participants (ICU and non‐ICU participants) in each group (the total calories received by the 8 and 10 ICU participants in each group were not reported). ^cNot reported in the abstract. The numbers are a crude estimation of kcal and grams of protein/kg/day from the whole sample data of height and BMI. BMI = Body Mass Index; g = gram; ICU = Intensive Care Unit; kcal = kilocalories; N/A: not available; SD = standard deviation; vs = versus

Table 2. Calories and protein received in both study groups

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Table 3. Main outcomes in individual studies ordered by the magnitude of the differences in calories received between the control and hypocaloric groups

Study	Difference in calories between groups (kcal/kg/day)	Hospital mortality (%) IG vs CG	ICU mortality (%) IG vs CG	Mortality at 30 days (%) IG vs CG	Infectious complications (%) IG vs CG	Length of hospital stay (days)^a IG vs CG	ICU length of stay (days)^a IG vs CG	Length of mechanical ventilation (days)^a IG vs CG	Categories denominated by the calories really received in the intervention and the control groups^b
Rugeles 2013	2.00	N/A	N/A	N/A	N/A	N/A	9.5 vs 10.4	8.5 vs 9.7	Hypocaloric vs hypocaloric
Arabi 2011	2.55	30% vs 42.5%	17.5% vs 21.7%	18.3% vs 23.3%	44.2% vs 46.7%	70.2 vs 67.2	11.7 vs 14.5	10.6 vs 13.2	Hypocaloric vs hypocaloric
McCowen 2000	4.10	9.5% vs 15.8%	N/A	N/A	28.6% vs 52.6%	19 vs 17	N/A	N/A	Hypocaloric vs hypocaloric
Ibrahim 2002	4.28	26.7% vs 20%	N/A	N/A	30.7% vs 49.3%	16.7 vs 22.9	9.8 vs 13.6	8.1 vs 12.9	Very hypocaloric vs very hypocaloric
Charles 2014	5.00	7.3% vs 9.5%	N/A	N/A	56.1% vs 57.1%	35.2 vs 31	16.7 vs 13.6	10.8 vs 8.3	Hypocaloric vs hypocaloric
Arabi 2015	5.48	24.2% vs 27.6%	16.1% vs 19.1%	20.8% vs 21.8%	35.9% vs 37.9%	48.3 vs 54.4	15.8 vs 16.4	11.3 vs 13.5	Hypocaloric vs hypocaloric
Battistella 1997	7.00	7.4% vs 0%	7.4% vs 0%	N/A	48.2% vs 73.3%	27 vs 39	18 vs 29	15 vs 27	Normocaloric vs normocaloric
Rugeles 2016	7.90	N/A	N/A	30% vs 26.7%	N/A	N/A	13.2 vs 13.5	10.8 vs 10.8	Hypocaloric vs hypocaloric
Petros 2016	8.40	37% vs 31.5%	21.7% vs 22.2%	39.1% vs 33.3%	28.3% vs 11.1%	38.1 vs 27.4	22.4 vs 17	20.7 vs 12.4	Hypocaloric vs hypocaloric
Ahrens 2005	10.40	N/A	N/A	N/A	25% vs 10%	23.4 vs 27.8	16.8 vs 23	11.1 vs 20.3	Normocaloric vs hypercaloric
NHLBI 2012	11.05	N/A	N/A	19.5% vs 19.3%	18.9% vs 16.1%	N/A	11.5 vs 11	10.5 vs 10.2	Very hypocaloric vs hypocaloric
Rice 2011	13.71	22.4% vs 19.6%	N/A	22.4% vs 19.6%	30.6% vs 32.4%	N/A	8.1 vs 7.6	5.7 vs 6.2	Very hypocaloric vs hypocaloric
Choban 1997	14.00	0% vs 29%	N/A	N/A	N/A	48 vs 45	N/A	N/A	Hypocaloric vs normocaloric
Norouzy 2013	N/A	N/A	N/A	10% vs 3.3%	N/A	19.9 vs 35.6	N/A	4.7 vs 17.9	N/A
Theodorakopoulou 2016	N/A	N/A	N/A	18.4% vs 28.9%	N/A	N/A	N/A	N/A	Hypocaloric vs normocaloric
^aLengths of hospital, ICU stays and of mechanical ventilation presented in mean days. ^bCategories denominated by the amount of calories really received by both study groups, according to the following: very hypocaloric = < 10 kcal/kg/day; hypocaloric = ≥ 10 to < 25 kcal/kg/day; normocaloric = ≥ 25 to < 35 kcal/kg/day; hypercaloric = ≥ 35 kcal/kg/day. IG = Intervention Group; CG = Control Group; N/A = Not available; vs = versus

Table 3. Main outcomes in individual studies ordered by the magnitude of the differences in calories received between the control and hypocaloric groups

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Table 4. Subgroup analyses

Subgroup	N participants (n studies)	Subgroup testing
1. Nutrition status
1.1. Length of hospital stay
Obese	13 (1 RCT)	I² = 0%, P = 0.76
General	1664 (9 RCTs)
2. Route of nutrition support
2.1. Length of hospital stay
Parenteral	150 (4 RCTs)	I² = 0%, P = 0.72
Enteral	1725 (6 RCTs)
2.2. Length of ICU stay
Parenteral	75 (2 RCTs)	I² = 83.3%, P < 0.01
Enteral	2867 (9 RCTs)
2.3. Infectious complications
Parenteral	137 (3 RCTs)	I² = 0%, P = 0.35
Enteral	2667 (7 RCTs)
2.4. Length of mechanical ventilation
Parenteral	73 (2 RCTs)	I² = 85.4%, P < 0.01
Enteral	2927 (10 RCTs)
3. Type of participant
3.1. Length of hospital stay
Surgical participants	223 (5 RCTs)	I² = 0%, P = 0.55
Medical participants	1354 (5 RCTs)
3.2. Length of ICU stay
Surgical participants	158 (3 RCTs)	I² = 0%, P = 0.52
Medical participants	2784 (8 RCTs)
3.3. Infectious complications
Surgical participants	220 (4 RCTs)	I² = 0%, P = 0.45
Medical participants	2584 (6 RCTs)
3.4. Length of mechanical ventilation
Surgical participants	156 (3 RCTs)	I² = 0%, P = 0.45
Medical participants	2854 (9 RCTs)
4. Amount of calories received by each study group
4.1. Length of hospital stay
Normo‐hypercaloric	97 (2 RCTs)	I² = 84.1%, P < 0.01
Hypocaloric	1370 (6 RCT)
Very hypocaloric	150 ( RCT)
4.2. Length of ICU stay
Normo‐hypercaloric	75 (2 RCTs)	I² = 0%, P = 0.42
Hypocaloric	1517 (6 RCTs)
Very hypocaloric	1350 (3 RCTs)
4.3. Infectious complications
Normo‐hypercaloric	97 (2 RCTs)	I² = 0%, P = 0.94
Hypocaloric	1357 (5 RCTs)
Very hypocaloric	1350 (3 RCTs)
4.4. Length of mechanical ventilation
Normo‐hypercaloric	73 (2 RCTs)	I² = 73.1%, P = 0.02
Hypocaloric	1517 (6 RCTs)
Very hypocaloric	1350 (3 RCTs)
RCT = randomized controlled trial; ICU = Intensive care unit

Table 4. Subgroup analyses

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Comparison 1. Hypocaloric nutrition (intervention) vs. Control

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mortality in hospital Show forest plot	9		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Mortality in ICU Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Mortality at 30 days Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 Length of Hospital stay (days) Show forest plot	10		Mean Difference (IV, Random, 95% CI)	Totals not selected

5 Length of ICU stay (days) Show forest plot	11		Mean Difference (IV, Random, 95% CI)	Totals not selected

6 Infectious complications Show forest plot	10		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

7 Length of mechanical ventilation (days) Show forest plot	12		Mean Difference (IV, Random, 95% CI)	Totals not selected

8 Non‐infectious complications (diarrhoea) Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

9 Hyperglycaemia Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

10 Hypoglicaemia Show forest plot	5		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected

11 Nitrogen balance (g/day) Show forest plot	3		Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 1. Hypocaloric nutrition (intervention) vs. Control

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