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Conservative versus liberal fluid therapy in patients with liver disease admitted to the intensive care unit.

Efficacy and safety of conservative versus liberal fluid therapy in critically ill patients with cirrhosis admitted to the intensive care unit

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000377538
Acronym
FliC
Enrollment
40
Registered
2015-04-23
Start date
2015-04-30
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with advanced chronic liver disease often become critically ill for many reasons including serious infections. When this occurs, their blood pressure may fall to dangerous levels and they may require admission to the Intensive Care Unit for treatment with intravenous fluids and infusions of drugs to support their circulation. The ideal amount of fluid to give to these patients is currently unknown and doctors currently choose what they believe is the best amount based on limited evidence. Some doctors prefer to give a lot of fluid and some prefer to give less, but it is unclear which strategy works best to help the patient and avoid complications. This study will try to work out the which of these two currently used treatment strategies is better for patients.

Interventions

Patients admitted to intensive care with decompensated cirrhosis requiring vasoactive infusions and fluid resuscitation guided by invasive haemodynamic monitoring will be randomly allocated to a fluid administration strategy which uses either a conservative approach or a liberal approach to intravenous fluid administration. Both strategies are currently accepted approaches to managing patients with cirrhosis in the ICU and either is presently utilised according to clinician preference, with the

Patients admitted to intensive care with decompensated cirrhosis requiring vasoactive infusions and fluid resuscitation guided by invasive haemodynamic monitoring will be randomly allocated to a fluid administration strategy which uses either a conservative approach or a liberal approach to intravenous fluid administration. Both strategies are currently accepted approaches to managing patients with cirrhosis in the ICU and either is presently utilised according to clinician preference, with the choice currently being made in the absence of evidence that one or the other may be better. Intensive care practice involves bedside nursing staff continuously assessing a patient's haemodynamic status and titrating vasoactive infusions and intravenous fluid therapy as guided by measured circulatory parameters with advice from attending medical staff. After four days of therapy guided by the study protocol allocation, ongoing management will revert to whatever approach is preferred by the treating ICU clinicians. The study protocol will only apply during ICU based care and will cease on discharge to ward-based care if this occurs prior to four days of intensive care management. Adherence to study protocol will be evaluated on a twice daily basis during clinical rounds. If the patient is allocated to the ‘Liberal IV’ fluid group the following management applies: 1. Circulatory aims a. Central venous pressure (CVP) = or greater than 12mmHg b. Mean arterial pressure (MAP) = or greater than 65mmHg c. After the second day in the ICU, patients are to have = or greater than 2000ml total daily positive fluid balance. 2. Management a. If CVP < or equal to 8mmHg, administer 500ml bolus of 4% albumin regardless of MAP (unless contra-indicated by clinical status e.g. severe pulmonary oedema) b. If MAP < or equal to 65 mmHg and CVP < or equal to 12 mmHg, administer 500ml bolus of 4% albumin c. If MAP < or equal to 65 and CVP = or greater than 12 mmHg, titrate noradrenaline infusion via central venous catheter to achieve MAP = or greater than 65mmHg d. Administer 100ml of 20% albumin twice daily, unless; i. Total net fluid balance is = or greater than 8000ml over two consecutive days ii. Serum albumin = or greater than 35 g/L iii. Further albumin or fluid administration is contra-indicated (e.g. patient has pulmonary oedema) 3. Fluid management in the intensive care unit a. If there is a demonstrable clinical need to modify the fluid regimen then such clinical considerations over-ride the study protocol. That is, more or less fluid of any type can be used if that is what is believed by the treating clinician to be in the patient’s best interests. If the patient is allocated to the ‘Restrictive IV’ fluid group the following management applies: 1. Circulatory aims a. Central venous pressure (CVP) = or less than 6mmHg b. Mean arterial pressure (MAP) = or greater than 65mmHg c. Cardiac index = or greater than 2.5 d. Even fluid net daily fluid balance from after the second day in ICU 2. Management a. If CVP < 6mmHg, administer 500ml bolus of 4% albumin b. If MAP = or greater than 65mmHg and CI = or greater than 2.5, administer no fluid except for enteral nutritional and intravenous replacement of measured/estimated losses c. If MAP < or equal to 65mmHg and CI < 2.5, administer 500ml bolus of 4% albumin d. If MAP < or equal to 65 mmHg and CI = or greater than 2.5, titrate noradrenaline infusion rate to achieve MAP = or greater than 65mmHg. i. If noradrenaline infusion rate > 30 mcg/minute (or > 0.4 mcg/kg/min), give 500ml of 4% albumin and manage in accordance with clinician preference. 3. Fluid management in the intensive care unit a. If there is a demonstrable clinical need to modify the fluid regimen then such clinical considerations over-ride the study protocol. That is, more or less fluid of any type can be used if that is what is believed by the treating clinician to be in the patient’s best interests. All participating patients will undergo a brief echocardiography assessment; 1. at enrolment, 2. after 48 hours of protolised management, 3. prior to discharge from ICU.

Sponsors

Professor Rinaldo Bellomo
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults (>18 years) admitted to ICU with decompensated cirrhosis 2. Hypotension (Mean Arterial Pressure (MAP) <65mmHg) 3. Clinical need for of a Central Venous Catheter (CVC) and arterial line (capable of cardiac output measurement (e.g. PiCCO or FloTrac)

Exclusion criteria

*Fulminant Hepatic Failure *Oliguria requiring frusemide administration via a continuous infusion prior to or immediately on admission to ICU *Renal failure requiring renal replacement therapy prior to or immediately on admission to ICU *Diagnosis of Acute Respiratory Distress Syndrome (ARDS) New, bilateral pulmonary infiltrates evident on chest X-Ray Absence of clinical evidence for, or measured findings of left atrial hypertension PaO2:FiO2 ratio of <200 *Severe pre-existing cardiopulmonary disease, e.g.; NYHA class III or IV heart failure Pulmonary hypertension *Admission to ICU for severe bleeding (e.g. oesophageal varices complicated by haemorrhage) *Requirement for total parenteral nutrition (TPN)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026