Trial · NCT03668236

The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial

NCT03668236, Phase 4, Completed, Anders Perner, MD, PhD; results first posted 2025-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial. Trials, record NCT03668236. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03668236

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Conservative vs. Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care Trial
NCT number: NCT03668236
Status: Completed
Phases: Phase 4
Enrollment: 1,554 participants, actual
Lead sponsor: Anders Perner, MD, PhD
Conditions: Septic Shock
Interventions: Isotonic crystalloids
First posted: 2018-09-12
Last updated: 2025-02-24
Results first posted: 2025-02-24

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	90-day Mortality	Day 90 after randomisation	Al cause mortality at 90 days
Secondary	Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU	Until ICU discharge, maximum 90 days	SAEs were defined as ischaemic events (cerebral, cardiac, intestinal or limb ischaemia) or as a new episode of severe acute kidney injury (modified KDIGO-3)
Secondary	Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids in the ICU.	Until ICU discharge, maximum 90 days	The pre-specified SARs to IV crystalloids were: Generalized tonic-clonic seizures, anaphylactic reactions, central pontine myelinolysis, severe hypernatremia, severe hyperchloremic acidosis, and severe metabolic alkalosis. Data on the outcome measures, including SARs, were obtained from patient medical records by the trial investigators or their delegates.
Secondary	Days Alive at Day 90 Without Life Support (Vasopressor / Inotropic Support, Invasive Mechanical Ventilation or Renal Replacement Therapy)	Until ICU discharge, maximum 90 days
Secondary	Days Alive and Out of Hospital at Day 90	Day 90 after randomisation
Secondary	All-cause Mortality at 1-year After Randomisation	1-year after randomisation
Secondary	Health-related Quality of Life 1 Year After Randomisation	1 year after randomisation	Measured using the EuroQoL EQ-5D-5L questionnaire (comprising 5 questions with a score from 1 to 5 each and a visual analogue scale from 0 to 100). Participants who have died will be assigned the lowest possible scores.
Secondary	Cognitive Function 1-year After Randomisation	1-year after randomisation	Assessed by the Montreal Cognitive Assessment (MoCa) MINI score validated for telephone use. Mini MoCA consists of 4 cognitive dimensions: attention (immediate recall of 5 words), executive functions and language (1-min verbal fluency), orientation (6 items on date and geographic orientation), and memory (delayed recall and recognition of 5 previously learned words). The total score ranges from 0 to 30, with lower values indicating worse cognitive function. To correct for any educational effect on the cognitive test, 1 point is added for participants with 12 years of education or less (scores were truncated at the maximum upper value of 30 points) Participants who had died were assigned the value 0.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	90-day Mortality	Day 90 after randomisation	Primary outcome data were missing from six patients in the restrictive-fluid group and three in the standard-fluid group.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU	Until ICU discharge, maximum 90 days	All secondary outcome data were missing for 23 patients (15 patients in the restrictive-fluid group and 8 in the standard-fluid group). In the analysis of SAEs in the ICU, additional 9 patients (5 in the restrictive-fluid group and 4 in the standard-fluid group) had missing data for severe acute kidney injury. One of the 5 patients in the restrictive-fluid group had another SAE; thus only 8 patients had missing data in the composite outcome.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids in the ICU.	Until ICU discharge, maximum 90 days	All secondary outcome data were missing for 23 patients (15 patients in the restrictive-fluid group and 8 in the standard-fluid group).	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Days Alive at Day 90 Without Life Support (Vasopressor / Inotropic Support, Invasive Mechanical Ventilation or Renal Replacement Therapy)	Until ICU discharge, maximum 90 days	All secondary outcome data were missing for 23 patients (15 patients in the restrictive-fluid group and 8 in the standard-fluid group).	days	MEDIAN
SECONDARY	Days Alive and Out of Hospital at Day 90	Day 90 after randomisation	All secondary outcome data were missing for 23 patients (15 patients in the restrictive-fluid group and 8 in the standard-fluid group).	days	MEDIAN
SECONDARY	All-cause Mortality at 1-year After Randomisation	1-year after randomisation		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Health-related Quality of Life 1 Year After Randomisation	1 year after randomisation	In total, 46 patients in the restrictive group and 55 in the standard group had missing data (either completely missing or partially missing) for EQ-5D-5L index values.	EQ-5D-5L index values	MEDIAN
SECONDARY	Cognitive Function 1-year After Randomisation	1-year after randomisation	In total, 82 patients in the restrictive group and 98 in the standard group had missing data (either completely missing or partially missing) for Mini MOCA.	Units on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
90-day Mortality	Fluid Restriction Group	323		Participants
90-day Mortality	Standard-care	329		Participants
Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU	Fluid Restriction Group	221		Participants
Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU	Standard-care	238		Participants
Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids in the ICU.	Fluid Restriction Group	31		Participants
Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids in the ICU.	Standard-care	32		Participants
Days Alive at Day 90 Without Life Support (Vasopressor / Inotropic Support, Invasive Mechanical Ventilation or Renal Replacement Therapy)	Fluid Restriction Group	77	Inter-Quartile Range 1 to 87	days
Days Alive at Day 90 Without Life Support (Vasopressor / Inotropic Support, Invasive Mechanical Ventilation or Renal Replacement Therapy)	Standard-care	77	Inter-Quartile Range 1 to 87	days
Days Alive and Out of Hospital at Day 90	Fluid Restriction Group	21	Inter-Quartile Range 0 to 69	days
Days Alive and Out of Hospital at Day 90	Standard-care	33	Inter-Quartile Range 0 to 70	days

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomization	STARTED	Fluid Restriction Group	770
Randomization	STARTED	Standard-care	784
Randomization	COMPLETED	Fluid Restriction Group	770
Randomization	COMPLETED	Standard-care	784
Randomization	NOT COMPLETED	Fluid Restriction Group	0
Randomization	NOT COMPLETED	Standard-care	0
90-day Follow-up	STARTED	Fluid Restriction Group	770
90-day Follow-up	STARTED	Standard-care	784
90-day Follow-up	COMPLETED	Fluid Restriction Group	764
90-day Follow-up	COMPLETED	Standard-care	781

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events10

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Cerebral ischemia	General disorders	Fluid Restriction Group	17	755
serious	Cerebral ischemia	General disorders	Standard-care	18	776
serious	Myocardial ischemia	General disorders	Fluid Restriction Group	16	755
serious	Myocardial ischemia	General disorders	Standard-care	6	776
serious	Intestinal ischemia	General disorders	Fluid Restriction Group	41	755
serious	Intestinal ischemia	General disorders	Standard-care	44	776
serious	Limb ischemia	General disorders	Fluid Restriction Group	18	755
serious	Limb ischemia	General disorders	Standard-care	18	776
serious	Severe acute kidney injury	General disorders	Fluid Restriction Group	173	750
serious	Severe acute kidney injury	General disorders	Standard-care	189	772

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Fluid Restriction Group	385	764
Total, all-cause mortality	Standard-care	383	781
Total, other adverse events	Fluid Restriction Group	0	755
Total, other adverse events	Standard-care	0	776
Total, serious adverse events	Fluid Restriction Group	221	755
Total, serious adverse events	Standard-care	238	776

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27686349	BACKGROUND	PubMed
31276193	BACKGROUND	PubMed
31828753	DERIVED	PubMed
31982391	DERIVED	PubMed
35709019	BACKGROUND	PubMed
37330928	DERIVED	PubMed
38576165	DERIVED	PubMed
40272936	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons6

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Fluid Restriction Group vs Standard-care: 90-day Mortality	Trial comparisons
Fluid Restriction Group vs Standard-care: All-cause Mortality at 1-year After Randomisation	Trial comparisons
Fluid Restriction Group vs Standard-care: Number of Participants With One or More Serious Adverse Reactions (SARs) to IV Crystalloids in the ICU.	Trial comparisons
Fluid Restriction Group vs Standard-care: Number of Participants With One or More Serious Adverse Events (SAEs) in the ICU	Trial comparisons
Fluid Restriction Group vs Standard-care: deaths from any cause	Trial comparisons
Fluid Restriction Group vs Standard-care: serious adverse events	Trial comparisons

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

Test	Named as
Verbal Fluency	Secondary outcome

Source ConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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