Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial

Peter B Hjortrup; Nicolai Haase; Helle Bundgaard; Simon L Thomsen; Robert Winding; Ville Pettilä; Anne Aaen; David Lodahl; Rasmus E Berthelsen; Henrik Christensen; Martin B Madsen; Per Winkel; Jørn Wetterslev; Anders Perner; CLASSIC Trial Group

doi:10.1007/s00134-016-4500-7

Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial

Peter B Hjortrup, Nicolai Haase, Helle Bundgaard, Simon L Thomsen, Robert Winding, Ville Pettilä, Anne Aaen, David Lodahl, Rasmus E Berthelsen, Henrik Christensen, Martin B Madsen, Per Winkel, Jørn Wetterslev, Anders Perner, CLASSIC Trial Group

Department of Clinical Medicine

155 Citations (Scopus)

Abstract

Purpose: We assessed the effects of a protocol restricting resuscitation fluid vs. a standard care protocol after initial resuscitation in intensive care unit (ICU) patients with septic shock. Methods: We randomised 151 adult patients with septic shock who had received initial fluid resuscitation in nine Scandinavian ICUs. In the fluid restriction group fluid boluses were permitted only if signs of severe hypoperfusion occurred, while in the standard care group fluid boluses were permitted as long as circulation continued to improve. Results: The co-primary outcome measures, resuscitation fluid volumes at day 5 and during ICU stay, were lower in the fluid restriction group than in the standard care group [mean differences −1.2 L (95 % confidence interval −2.0 to −0.4); p < 0.001 and −1.4 L (−2.4 to −0.4) respectively; p < 0.001]. Neither total fluid inputs and balances nor serious adverse reactions differed statistically significantly between the groups. Major protocol violations occurred in 27/75 patients in the fluid restriction group. Ischaemic events occurred in 3/75 in the fluid restriction group vs. 9/76 in the standard care group (odds ratio 0.32; 0.08–1.27; p = 0.11), worsening of acute kidney injury in 27/73 vs. 39/72 (0.46; 0.23–0.92; p = 0.03), and death by 90 days in 25/75 vs. 31/76 (0.71; 0.36–1.40; p = 0.32). Conclusions: A protocol restricting resuscitation fluid successfully reduced volumes of resuscitation fluid compared with a standard care protocol in adult ICU patients with septic shock. The patient-centred outcomes all pointed towards benefit with fluid restriction, but our trial was not powered to show differences in these exploratory outcomes. Trial registration: NCT02079402.

Original language	English
Journal	Intensive Care Medicine
Volume	42
Issue number	11
Pages (from-to)	1695-1705
Number of pages	11
ISSN	0342-4642
DOIs	https://doi.org/10.1007/s00134-016-4500-7
Publication status	Published - 1 Nov 2016

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Hjortrup, P. B., Haase, N., Bundgaard, H., Thomsen, S. L., Winding, R., Pettilä, V., Aaen, A., Lodahl, D., Berthelsen, R. E., Christensen, H., Madsen, M. B., Winkel, P., Wetterslev, J., Perner, A., & CLASSIC Trial Group (2016). Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial. Intensive Care Medicine, 42(11), 1695-1705. https://doi.org/10.1007/s00134-016-4500-7

Restricting volumes of resuscitation fluid in adults with septic shock after initial management : the CLASSIC randomised, parallel-group, multicentre feasibility trial. / Hjortrup, Peter B; Haase, Nicolai; Bundgaard, Helle et al.

In: Intensive Care Medicine, Vol. 42, No. 11, 01.11.2016, p. 1695-1705.

Research output: Contribution to journal › Journal article › Research › peer-review

Hjortrup, PB, Haase, N, Bundgaard, H, Thomsen, SL, Winding, R, Pettilä, V, Aaen, A, Lodahl, D, Berthelsen, RE, Christensen, H, Madsen, MB, Winkel, P, Wetterslev, J, Perner, A & CLASSIC Trial Group 2016, 'Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial', Intensive Care Medicine, vol. 42, no. 11, pp. 1695-1705. https://doi.org/10.1007/s00134-016-4500-7

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abstract = "Purpose: We assessed the effects of a protocol restricting resuscitation fluid vs. a standard care protocol after initial resuscitation in intensive care unit (ICU) patients with septic shock. Methods: We randomised 151 adult patients with septic shock who had received initial fluid resuscitation in nine Scandinavian ICUs. In the fluid restriction group fluid boluses were permitted only if signs of severe hypoperfusion occurred, while in the standard care group fluid boluses were permitted as long as circulation continued to improve. Results: The co-primary outcome measures, resuscitation fluid volumes at day 5 and during ICU stay, were lower in the fluid restriction group than in the standard care group [mean differences −1.2 L (95 % confidence interval −2.0 to −0.4); p < 0.001 and −1.4 L (−2.4 to −0.4) respectively; p < 0.001]. Neither total fluid inputs and balances nor serious adverse reactions differed statistically significantly between the groups. Major protocol violations occurred in 27/75 patients in the fluid restriction group. Ischaemic events occurred in 3/75 in the fluid restriction group vs. 9/76 in the standard care group (odds ratio 0.32; 0.08–1.27; p = 0.11), worsening of acute kidney injury in 27/73 vs. 39/72 (0.46; 0.23–0.92; p = 0.03), and death by 90 days in 25/75 vs. 31/76 (0.71; 0.36–1.40; p = 0.32). Conclusions: A protocol restricting resuscitation fluid successfully reduced volumes of resuscitation fluid compared with a standard care protocol in adult ICU patients with septic shock. The patient-centred outcomes all pointed towards benefit with fluid restriction, but our trial was not powered to show differences in these exploratory outcomes. Trial registration: NCT02079402.",

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T1 - Restricting volumes of resuscitation fluid in adults with septic shock after initial management

T2 - the CLASSIC randomised, parallel-group, multicentre feasibility trial

AU - Hjortrup, Peter B

AU - Haase, Nicolai

AU - Bundgaard, Helle

AU - Thomsen, Simon L

AU - Winding, Robert

AU - Pettilä, Ville

AU - Aaen, Anne

AU - Lodahl, David

AU - Berthelsen, Rasmus E

AU - Christensen, Henrik

AU - Madsen, Martin B

AU - Winkel, Per

AU - Wetterslev, Jørn

AU - Perner, Anders

AU - CLASSIC Trial Group

PY - 2016/11/1

Y1 - 2016/11/1

N2 - Purpose: We assessed the effects of a protocol restricting resuscitation fluid vs. a standard care protocol after initial resuscitation in intensive care unit (ICU) patients with septic shock. Methods: We randomised 151 adult patients with septic shock who had received initial fluid resuscitation in nine Scandinavian ICUs. In the fluid restriction group fluid boluses were permitted only if signs of severe hypoperfusion occurred, while in the standard care group fluid boluses were permitted as long as circulation continued to improve. Results: The co-primary outcome measures, resuscitation fluid volumes at day 5 and during ICU stay, were lower in the fluid restriction group than in the standard care group [mean differences −1.2 L (95 % confidence interval −2.0 to −0.4); p < 0.001 and −1.4 L (−2.4 to −0.4) respectively; p < 0.001]. Neither total fluid inputs and balances nor serious adverse reactions differed statistically significantly between the groups. Major protocol violations occurred in 27/75 patients in the fluid restriction group. Ischaemic events occurred in 3/75 in the fluid restriction group vs. 9/76 in the standard care group (odds ratio 0.32; 0.08–1.27; p = 0.11), worsening of acute kidney injury in 27/73 vs. 39/72 (0.46; 0.23–0.92; p = 0.03), and death by 90 days in 25/75 vs. 31/76 (0.71; 0.36–1.40; p = 0.32). Conclusions: A protocol restricting resuscitation fluid successfully reduced volumes of resuscitation fluid compared with a standard care protocol in adult ICU patients with septic shock. The patient-centred outcomes all pointed towards benefit with fluid restriction, but our trial was not powered to show differences in these exploratory outcomes. Trial registration: NCT02079402.

AB - Purpose: We assessed the effects of a protocol restricting resuscitation fluid vs. a standard care protocol after initial resuscitation in intensive care unit (ICU) patients with septic shock. Methods: We randomised 151 adult patients with septic shock who had received initial fluid resuscitation in nine Scandinavian ICUs. In the fluid restriction group fluid boluses were permitted only if signs of severe hypoperfusion occurred, while in the standard care group fluid boluses were permitted as long as circulation continued to improve. Results: The co-primary outcome measures, resuscitation fluid volumes at day 5 and during ICU stay, were lower in the fluid restriction group than in the standard care group [mean differences −1.2 L (95 % confidence interval −2.0 to −0.4); p < 0.001 and −1.4 L (−2.4 to −0.4) respectively; p < 0.001]. Neither total fluid inputs and balances nor serious adverse reactions differed statistically significantly between the groups. Major protocol violations occurred in 27/75 patients in the fluid restriction group. Ischaemic events occurred in 3/75 in the fluid restriction group vs. 9/76 in the standard care group (odds ratio 0.32; 0.08–1.27; p = 0.11), worsening of acute kidney injury in 27/73 vs. 39/72 (0.46; 0.23–0.92; p = 0.03), and death by 90 days in 25/75 vs. 31/76 (0.71; 0.36–1.40; p = 0.32). Conclusions: A protocol restricting resuscitation fluid successfully reduced volumes of resuscitation fluid compared with a standard care protocol in adult ICU patients with septic shock. The patient-centred outcomes all pointed towards benefit with fluid restriction, but our trial was not powered to show differences in these exploratory outcomes. Trial registration: NCT02079402.

KW - Journal Article

U2 - 10.1007/s00134-016-4500-7

DO - 10.1007/s00134-016-4500-7

M3 - Journal article

C2 - 27686349

SN - 0935-1701

VL - 42

SP - 1695

EP - 1705

JO - European Journal of Intensive Care Medicine

JF - European Journal of Intensive Care Medicine

IS - 11

ER -

Restricting volumes of resuscitation fluid in adults with septic shock after initial management: the CLASSIC randomised, parallel-group, multicentre feasibility trial

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