Introduction
Materials and methods
Participants
Assessment of HRQoL
Assessment of pruritus
Statistical analyses
Results
Responders (n= 190) | Nonresponders (n= 105) | P value | |
---|---|---|---|
Allocated to HES - n (%)
| 98 (52) | 42 (40) | 0.06 |
Age - years
| 66 (59-74) | 56 (49-66) | < 0.0001 |
Male gender - no. (%)
| 105 (55) | 65 (62) | 0.27 |
Included at university hospital - no. (%)
| 71 (37) | 37 (35) | 0.72 |
Surgery
1
- no. (%)
| |||
Emergency | 64 (34) | 29 (28) | 0.28 |
Elective | 24 (13) | 10 (10) | 0.42 |
Source of sepsis
2
- no. (%)
| |||
Lungs | 80 (42) | 59 (56) | - |
Abdomen | 73 (38) | 24 (23) | - |
Urinary tract | 26 (14) | 15 (14) | - |
Soft tissue | 23 (12) | 15 (14) | - |
Other | 22 (12) | 8 (8) | - |
SAPS II
| 49 (38-58) | 47 (34-55) | 0.16 |
SOFA score
3
| 7 (5-9) | 7 (5-9) | 0.64 |
Shock
4
- no. (%)
| 160 (84) | 76 (72) | 0.02 |
Acute kidney injury
5
- no. (%)
| 71 (37) | 34 (32) | 0.39 |
Mechanical ventilation - no. (%)
| 98 (52) | 59 (56) | 0.45 |
Comorbidities
| |||
Diabetes mellitus - no. (%) | 28 (15) | 23 (22) | 0.12 |
Arterial hypertension - no. (%) | 81 (43) | 33 (31) | 0.06 |
Chronic renal disease6 - no. (%) | 23 (13) | 20 (21) | 0.11 |
Hematological malignancy - no. (%) | 15 (8) | 3 (3) | 0.08 |
Previous admission for - no. (%)
| |||
Heart failure or myocardial infarction | 22 (12) | 9 (9) | 0.42 |
Stroke | 13 (7) | 11 (10) | 0.27 |
Asthma or COPD | 24 (13) | 15 (14) | 0.69 |
HES 130/0.42 (n= 98) | Ringer's acetate (n= 92) | |
---|---|---|
Time to follow-up - months
| 13 (9-17) | 14 (10-18) |
Age - years
| 66 (59-74) | 66 (58-75) |
Male gender - no. (%)
| 52 (53) | 53 (58) |
Included at university hospital - no. (%)
| 35 (36) | 36 (39) |
Surgery
1
- no. (%)
| ||
Emergency | 31 (32) | 33 (36) |
Elective | 7 (7) | 17 (18) |
Source of ICU admittance - no. (%)
| ||
Emergency department | 32 (33) | 21 (23) |
General ward | 40 (41) | 39 (42) |
Operating or recovery room | 17 (17) | 21 (23) |
Other ICU in the same hospital | 2 (2) | 2 (2) |
Other hospital | 7 (7) | 9 (10) |
Source of sepsis
2
- no. (%)
| ||
Lungs | 42 (43) | 38 (41) |
Abdomen | 40 (41) | 33 (36) |
Urinary tract | 13 (13) | 13 (14) |
Soft tissue | 9 (9) | 14 (15) |
Other | 10 (10) | 12 (13) |
Positive culture from blood or a sterile site - no. (%)
| 17 (17) | 11 (12) |
Time from ICU admission to randomization - hours
| 3 (1-11) | 3 (1-14) |
SAPS II
| 48 (36-58) | 50 (38-59) |
SOFA score
3
| 7 (5-9) | 7 (5-9) |
Shock
4
- no. (%)
| 80 (82) | 80 (87) |
Acute kidney injury
5
- no. (%)
| 36 (37) | 35 (38) |
Mechanical ventilation - no. (%)
| 44 (45) | 54 (59) |
Comorbidities
| ||
Diabetes mellitus - no. (%) | 12 (12) | 16 (17) |
Arterial hypertension - no. (%) | 42 (43) | 39 (42) |
Chronic renal disease6 - no. (%) | 9 (10) | 14 (17) |
Hematological malignancy - no. (%) | 6 (6) | 9 (10) |
Previous admission for - no. (%)
| ||
Heart failure or myocardial infarction | 10 (10) | 12 (13) |
Stroke | 7 (7) | 6 (7) |
Asthma or COPD | 12 (12) | 12 (13) |
Any ventilation in the ICU, n (%)
| 71 (72) | 72 (78) |
Days in ventilator if treated, median (IQR)
| 6 (3-14) | 5 (3-12) |
Any renal replacement therapy dialysis in the ICU, n (%)
| 18 (18) | 15 (16) |
Days in renal replacement therapy if treated, median (IQR)
| 7 (3-22) | 10 (6-22) |
Days in ICU, median (IQR)
| 6 (3-14) | 8 (4-14) |
Days in hospital in the 90 days follow-up period, median (IQR)
| 32 (20-50) | 30 (20-53) |
Data quality
Health-related quality of life
Imputation dataset | Complete case dataset | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
HES group | Ringer's group | HES group | Ringer's group | |||||||
Scale | N | IQR | N | IQR | P value | N | IQR | N | IQR | P -value |
Primary outcomes
| ||||||||||
PCS | 88 | 37 (29-48) | 83 | 40 (32-51) | 0.23 | 74 | 38 (29-48) | 63 | 42 (33-52) | 0.15 |
MCS | 88 | 45 (36-55) | 83 | 53 (39-60) | 0.01 | 74 | 46 (35-56) | 63 | 54 (41-59) | 0.02 |
Secondary outcomes
| ||||||||||
PF | 94 | 50 (20-75) | 86 | 65 (30-85) | 0.17 | 91 | 50 (20-75) | 81 | 65 (30-85) | 0.23 |
RP | 87 | 0 (0-75) | 82 | 13 (0-75) | 0.63 | 85 | 0 (0-75) | 79 | 25 (0-75) | 0.46 |
BP | 95 | 52 (31-84) | 86 | 73 (42-100) | 0.007 | 91 | 52 (31-84) | 83 | 72 (42-100) | 0.02 |
GH | 95 | 42 (30-62) | 87 | 52 (25-72) | 0.35 | 86 | 41 (30-62) | 80 | 52 (30-72) | 0.19 |
VT | 94 | 45 (29-60) | 85 | 55 (35-75) | 0.008 | 92 | 45 (28-60) | 82 | 55 (35-75) | 0.004 |
SF | 93 | 75 (38-100) | 86 | 88 (63-100) | 0.03 | 88 | 75 (38-100) | 81 | 75 (63-100) | 0.07 |
RE | 87 | 33 (0-100) | 81 | 67 (0-100) | 0.19 | 84 | 33 (0-100) | 78 | 67 (0-100) | 0.18 |
MH | 93 | 64 (52-82) | 86 | 80 (60-92) | 0.004 | 91 | 64 (52-84) | 85 | 80 (60-92) | 0.006 |
Pruritus
HES 130/0.42 | Ringer's acetate | Relative risk (95%CI) | P value | |
---|---|---|---|---|
Primary outcome
| ||||
Pruritus at any time after discharge, n/N (%) | 47/96 (49) | 38/88 (43) | 1.13 (0.83-1.55) | 0.43 |
Secondary outcomes
| ||||
Pruritus in the last 48 hours, n/N (%) | 31/95 (33) | 24/89 (27) | 1.21 (0.77-1.89) | 0.40 |
VAS score, median (IQR)* | 4.5 (3.5-5.5) | 3.5 (2.0-6.5) | - | 0.28 |
Action taken against pruritus n/N (%) | 36/96 (37) | 20/88 (23) | 1.65 (1.04-2.62) | 0.03 |
Use of ointment/tablets n/N (%) | 36/96 (37) | 19/88 (21) | 1.74 (1.08-2.79) | 0.02 |
Consulted GP n/N (%) | 11/96 (11) | 7/88 (8) | 1.26 (0.53-2.99) | 0.60 |
Consulted dermatologist n/N (%) | 2/96 (2) | 5/88 (6) | 0.37 (0.07-1.84) | 0.20 |
Discussion
Conclusions
Key messages
-
The study showed that survivors of severe sepsis treated with hydroxyethyl starch scored significantly lower in SF-36 than those treated with Ringer's solution. The differences were seen in the mental component summary score, and the vitality, mental health, social function and bodily pain scales.
-
The differences in frequency and severity of pruritus between the HES and Ringer's group were not statistically significant.
-
Pruritus was very frequent in the sepsis survivors in the present trial.