Trial · NCT03434028

Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis

NCT03434028, Phase 3, Completed, Massachusetts General Hospital; results first posted 2023-07-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis. Trials, record NCT03434028. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03434028

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Trial

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

Title: Crystalloid Liberal or Vasopressors Early Resuscitation in Sepsis
NCT number: NCT03434028
Status: Completed
Phases: Phase 3
Enrollment: 1,563 participants, actual
Lead sponsor: Massachusetts General Hospital
Conditions: Septic Shock
Interventions: Early Vasopressors, Early Fluids
First posted: 2018-02-15
Last updated: 2023-07-06
Results first posted: 2023-07-06
Limitations and caveats: All cause mortality: To clarify, we did not classify death as anticipated or not anticipated; nor did we collect cause of death for this trial.

Source ClinicalTrials.gov

Registered outcomes14

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

List	Outcome	Time frame	Description
Primary	Death Before Discharge Home by Day 90	From randomization to discharge home up to and including day 90.	The primary outcome was death from any cause before discharge home by day 90. Point estimates were from Kaplan-Meier curves. There were 109 deaths and 5 patients with censored data the restrictive fluid group and 116 deaths and 4 patients with censored data in the liberal group. We defined home as the same setting or a setting similar to the one where the patient resided before becoming ill. Thus, if a patient originated from a private residence and was discharged from the hospital to a rehabilitation setting, we assessed for vital status until return to the private residence.Vital status was determined using any of the following methods: medical record review, phone calls to patient, proxy or healthcare facility, review of obituaries, or information from the Centers for Disease Control and Prevention's National Death Index (NDI).
Secondary	Organ Support Free Days	28 days after randomization	Defined as a patient being alive and without assisted breathing, new renal replacement therapy, or vasopressors (excluding vasopressor use prior to 48 hours). Any day that a patient is alive and without organ support will represent days alive and free of organ support.
Secondary	Ventilator Free Days (VFD)	28 days after randomization	Ventilator-free days is defined to be 28 days minus the duration of mechanical ventilation through day 28. Participants who do not survive to day 28 are assigned zero ventilator-free days.
Secondary	Renal Replacement Free Days	28 days after randomization	The number of calendar days between randomization and 28 days later that the patient is alive and without renal replacement therapy. Patients who died prior to day 28 are assigned zero renal replacement free days.
Secondary	Vasopressor Free Days	From study day 2 through day 28	The number of calendar days between day 2 (eligibility starting 48 hours post randomization) and 26 days later that the patient is alive and without the use of vasopressor therapy. Patients who died prior to day 28 are assigned zero vasopressor free days.
Secondary	ICU Free Days	28 days after randomization	Defined as the number of days spent alive out of the ICU to day 28.
Secondary	Hospital Free Days to Discharge Home	28 days after randomization	Days alive post hospital discharge through day 28. Patients who die on or prior to day 28 are assigned zero hospital free days.
Secondary	New Intubation With Invasive Mechanical Ventilation by 28 Days	28 days after randomization	Patients who receive invasive mechanical ventilation via endotracheal or tracheostomy tube, except those intubated solely for a procedure and extubated within 24 hours, through to study day 28 meet this endpoint. Non-invasive mechanical ventilation will not be included as an outcome. This is a binary outcome.
Secondary	Initiation of Renal Replacement Therapy	28 days after randomization	Patients receiving (new) renal replacement therapy through day 28. Patients with chronic renal replacement therapy initiated prior to the current sepsis illness were not eligible to meet this endpoint.
Secondary	Kidney Disease: Change in Creatinine-based Global Outcomes (KIDGO) Score Between Baseline and 72 Hours	72 hours after randomization	Assessment of renal function using the KDIGO staging system (using serum creatinine criteria only) between baseline and 72 hours post randomization to assess for de novo acute kidney injury (AKI) (e.g., meeting criteria for AKI by KDIGO criteria) or worsening AKI (e.g., increasing severity). Patients on chronic renal replacement therapy were not eligible for this endpoint determination. Scoring of 1-3 (using serum creatinine levels; a higher score indicates worsening kidney function): 1. creatinine level 1.5-1.9 times baseline OR \>/= 0.3 mg/dl (\>/= 25.5 umol/l) increase 2. creatinine level 2.0-2.9 times baseline 3. creatinine level 3.0 times baseline OR increase in serum creatinine to \>/=4.0mg/dl (\>/= 353 umol/l) OR initiation of renal replacement therapy

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Death Before Discharge Home by Day 90	From randomization to discharge home up to and including day 90.	There were 109 deaths and 5 patients with censored data the restrictive fluid group. There were 116 deaths and 4 patients with censored data in the liberal group. Point estimates from the Kaplan-Meier curve.	percentage of participants	NUMBER
SECONDARY	Organ Support Free Days	28 days after randomization	We only report primary and secondary outcomes using available data without imputation. Because of missing data, the denominator may vary for selected outcomes as reported in the primary publication (PMID: 36688507).	days	MEAN
SECONDARY	Ventilator Free Days (VFD)	28 days after randomization		days	MEAN
SECONDARY	Renal Replacement Free Days	28 days after randomization		days	MEAN
SECONDARY	Vasopressor Free Days	From study day 2 through day 28		days	MEAN
SECONDARY	ICU Free Days	28 days after randomization		days	MEAN
SECONDARY	Hospital Free Days to Discharge Home	28 days after randomization		days	MEAN
SECONDARY	New Intubation With Invasive Mechanical Ventilation by 28 Days	28 days after randomization		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Initiation of Renal Replacement Therapy	28 days after randomization		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Kidney Disease: Change in Creatinine-based Global Outcomes (KIDGO) Score Between Baseline and 72 Hours	72 hours after randomization		score on a scale	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group28

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

Outcome	Group	Value	Spread	Units
Death Before Discharge Home by Day 90	Restrictive Fluids	14	95% Confidence Interval 11.6 to 16.4	percentage of participants
Death Before Discharge Home by Day 90	Liberal Fluids	14.9	95% Confidence Interval 12.4 to 17.4	percentage of participants
Organ Support Free Days	Restrictive Fluids	24	95% Confidence Interval 23.4 to 24.6	days
Organ Support Free Days	Liberal Fluids	23.6	95% Confidence Interval 23 to 24.3	days
Ventilator Free Days (VFD)	Restrictive Fluids	23.4	95% Confidence Interval 22.7 to 24.1	days
Ventilator Free Days (VFD)	Liberal Fluids	22.8	95% Confidence Interval 22 to 23.5	days
Renal Replacement Free Days	Restrictive Fluids	24.1	95% Confidence Interval 23.4 to 24.8	days
Renal Replacement Free Days	Liberal Fluids	23.9	95% Confidence Interval 23.2 to 24.6	days
Vasopressor Free Days	Restrictive Fluids	22	95% Confidence Interval 21.4 to 22.7	days
Vasopressor Free Days	Liberal Fluids	21.6	95% Confidence Interval 20.9 to 22.3	days

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Restrictive Fluids	782
Overall Study	STARTED	Liberal Fluids	781
Overall Study	COMPLETED	Restrictive Fluids	782
Overall Study	COMPLETED	Liberal Fluids	781
Overall Study	NOT COMPLETED	Restrictive Fluids	0
Overall Study	NOT COMPLETED	Liberal Fluids	0

Source ClinicalTrials.gov

Adverse events90

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
other	Chest Pain	Cardiac disorders	Restrictive Fluids	1	782
other	Chest Pain	Cardiac disorders	Liberal Fluids	0	781
other	Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Restrictive Fluids	1	782
other	Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Liberal Fluids	0	781
other	Seizure Vs Syncope Vasovagal	Nervous system disorders	Restrictive Fluids	1	782
other	Seizure Vs Syncope Vasovagal	Nervous system disorders	Liberal Fluids	0	781
other	Thrombosis Venous Deep	Vascular disorders	Restrictive Fluids	1	782
other	Thrombosis Venous Deep	Vascular disorders	Liberal Fluids	0	781
other	Anemia	Blood and lymphatic system disorders	Restrictive Fluids	0	782
other	Anemia	Blood and lymphatic system disorders	Liberal Fluids	2	781

1 to 10 of 90Source ClinicalTrials.gov

See all 90 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Restrictive Fluids	172	768
Total, all-cause mortality	Liberal Fluids	169	773
Total, other adverse events	Restrictive Fluids	4	782
Total, other adverse events	Liberal Fluids	14	781
Total, serious adverse events	Restrictive Fluids	18	782
Total, serious adverse events	Liberal Fluids	19	781

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
29753517	DERIVED	PubMed
36688507	DERIVED	PubMed
38992663	DERIVED	PubMed
40315385	DERIVED	PubMed
41632536	DERIVED	PubMed
42093058	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 comparisons7

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

Comparison	Source
Restrictive Fluids vs Liberal Fluids: Death From Any Cause at Any Location by Day 90	Trial comparisons
Restrictive Fluids vs Liberal Fluids: Initiation of Renal Replacement Therapy	Trial comparisons
Restrictive Fluids vs Liberal Fluids: New Onset Atrial or Ventricular Arrhythmia	Trial comparisons
Restrictive Fluids vs Liberal Fluids: Development of ARDS	Trial comparisons
Restrictive Fluids vs Liberal Fluids: deaths from any cause	Trial comparisons
Restrictive Fluids vs Liberal Fluids: New Intubation With Invasive Mechanical Ventilation by 28 Days	Trial comparisons
Restrictive Fluids vs Liberal Fluids: serious adverse events	Trial comparisons

Tests0

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

None in this release.

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.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03434028

GET https://conductscience.org/api/trials/v1/NCT03434028/results?page=2

API reference For AI assistants