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WATERFALL Trial – Fluid Resuscitation in Acute Pancreatitis
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When? This feed was archived on March 22, 2023 19:49 (). Last successful fetch was on February 16, 2023 22:14 ()
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Manage episode 347291570 series 2593358
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WATERFALL Trial – Fluid Resuscitation in Acute Pancreatitis
Dr Swapnil Pawar
Written by – Dr Jose Chacko
Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis
Hypoperfusion and hemoconcentration in acute pancreatitis may lead to necrosis, and adverse clinical outcomes.
Population
The WATERFALL multicenter, open-label, parallel-group, randomized, controlled, superiority trial, enrolled patients at 18 centres from India, Italy, Mexico, and Spain. Acute pancreatitis was diagnosed according to the revised Atlanta Classification. For inclusion in the study, patients were within 24 hours after pain onset and 8 hours or less since confirmation of diagnosis.
Excluded
- Patients who met the criteria for moderately severe or severe disease at baseline (shock, respiratory failure, and renal failure)
- Heart failure (New York Heart Association functional class II, III, or IV),
- Uncontrolled arterial hypertension; electrolyte abnormalities including hypernatremia, hyponatremia, hyperkalemia, hypercalcemia
- A life expectancy of less than 1 year
- Chronic pancreatitis
- Chronic renal failure
- Decompensated cirrhosis
Aggressive resuscitation
Bolus of lactated Ringer’s solution at 20 ml per kilogram of body over a period of 2 hours, followed by infusion at a rate of 3 ml per kilogram per hour.
Moderate resuscitation
Bolus of 10 ml/kg as bolus over 2 hours if hypovolemic; by 1.5 ml/kg/h as maintenance.
Both groups
Evaluation at 3 hours for fluid overload. Biochemical and physical assessments at 12, 24, 48, and 72 h; adjustments made to the rate of fluid administration; stopped if suspicion of fluid overload. Oral feeds at 12 h if pain intensity is less than 5 on the PAN-PROMISE scale. Fluid resuscitation stopped if oral intake was tolerated for more than 8 h, earliest at 20 h and 48 h after randomization in the moderate vs. aggressive groups, respectively.
Sample size
Based on an anticipated incidence of moderately severe or severe acute pancreatitis of 35%. A sample size of 744, with 372 patients in each group, for 80% power to detect a between-group difference of 10 percentage points at a two-sided significance level (alpha) of 0.05.
Two planned interim analysis after 248 and 496 patients. The study was terminated early due to safety concerns of fluid overload with the aggressive strategy.
Results
Aggressive: 122 patients; moderate: 127 patients. Baseline characteristics were well-matched.
Fluid administered during the first 48 h: Aggressive: 7.8 liters (interquartile range, 6.5 to 9.8) vs. Moderate: 5.5 liters (interquartile range, 4.0 to 6.8)
(Diagnosis of fluid overload: at least two of the following three criteria: symptoms, physical signs, and imaging evidence of hypervolemia; ARDS had to be ruled out
- Criterion 1: non-invasive evidence of heart failure (ie echo), radiographic evidence of pulmonary congestion, invasive cardiac cath suggesting heart failure.
- Criterion 2: Dyspnea
- Criterion 3: Heart failure signs: peripheral edema, pulmonary rales, increased JVP or hepatojugular reflex
Mild fluid overload: if it was responsive to medical therapy or decreased hydration and if the ratio of PaO2 to FiO2 never decreased to less than 300
Moderate fluid overload: if it was responsive to medical therapy or decreased hydration but the ratio of PaO2 to FiO2 was less than 300 at least once
Severe fluid overload: if mechanical ventilation or hemofiltration was required
Outcomes: Primary outcome, green; secondary outcomes, blue; safety outcomes, yellow
Outcome | Aggressive strategy | Moderate strategy | Significance |
Moderately severe or severe acute pancreatitis (Revised Atlanta Classification)
| 22.1% | 17.3% | NS |
Organ failure | 7.4% | 3.9% | NS |
Local complications | 20.5% | 16.5% | NS |
Persistent organ failure
| 6.6% | 1.6% | NS |
Respiratory failure | 7.4% | 2.4% | NS |
Necrotizing pancreatitis | 13.9% | 7.1% | NS |
ICU admission | 6.6% | 1.6% | NS |
Hospital LOS | 6 (4–8) d | 5 (3–7) d | NS |
PAN-PROMISE score | 23 (12–35) | 18 (10–31) | NS |
Fluid overload | 20.5% | 6.3% | RR, 2.85; 95% CI, 1.36 to 5.94) |
Fluid overload with symptoms | 18% | 7.9% | |
Fluid overload with signs | 26.2% | 11% | RR, 2.36; 95% CI, 1.33 to 4.19 |
Moderate to severe overload | 4.9% | 0.8% |
Strengths
- No loss to follow up
- Balanced baseline characteristics, except gall stone pancreatitis higher in the aggressive group
- Protocol-based fluid administration; assessment at regular time intervals at 3, 12, 24, 48, and 72 h
- Poorly reliable clinical signs were not followed in the assessment of fluid overload
- Focus on safety outcomes
Limitations
- Included only patients with mild pancreatitis
- Less co-morbidities
- Unblinded
- Sample size not achieved
- Assumed progression to moderately severe or severe pancreatitis of 35%; actual progression was only 20%
The post WATERFALL Trial – Fluid Resuscitation in Acute Pancreatitis first appeared on Critical Care Education.
42 επεισόδια
Αρχειοθετημένη σειρά ("Ανενεργό feed" status)
When? This feed was archived on March 22, 2023 19:49 (). Last successful fetch was on February 16, 2023 22:14 ()
Why? Ανενεργό feed status. Οι διακομιστές μας δεν ήταν σε θέση να ανακτήσουν ένα έγκυρο podcast feed για μια παρατεταμένη περίοδο.
What now? You might be able to find a more up-to-date version using the search function. This series will no longer be checked for updates. If you believe this to be in error, please check if the publisher's feed link below is valid and contact support to request the feed be restored or if you have any other concerns about this.
Manage episode 347291570 series 2593358
- play_arrow
WATERFALL Trial – Fluid Resuscitation in Acute Pancreatitis
Dr Swapnil Pawar
Written by – Dr Jose Chacko
Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis
Hypoperfusion and hemoconcentration in acute pancreatitis may lead to necrosis, and adverse clinical outcomes.
Population
The WATERFALL multicenter, open-label, parallel-group, randomized, controlled, superiority trial, enrolled patients at 18 centres from India, Italy, Mexico, and Spain. Acute pancreatitis was diagnosed according to the revised Atlanta Classification. For inclusion in the study, patients were within 24 hours after pain onset and 8 hours or less since confirmation of diagnosis.
Excluded
- Patients who met the criteria for moderately severe or severe disease at baseline (shock, respiratory failure, and renal failure)
- Heart failure (New York Heart Association functional class II, III, or IV),
- Uncontrolled arterial hypertension; electrolyte abnormalities including hypernatremia, hyponatremia, hyperkalemia, hypercalcemia
- A life expectancy of less than 1 year
- Chronic pancreatitis
- Chronic renal failure
- Decompensated cirrhosis
Aggressive resuscitation
Bolus of lactated Ringer’s solution at 20 ml per kilogram of body over a period of 2 hours, followed by infusion at a rate of 3 ml per kilogram per hour.
Moderate resuscitation
Bolus of 10 ml/kg as bolus over 2 hours if hypovolemic; by 1.5 ml/kg/h as maintenance.
Both groups
Evaluation at 3 hours for fluid overload. Biochemical and physical assessments at 12, 24, 48, and 72 h; adjustments made to the rate of fluid administration; stopped if suspicion of fluid overload. Oral feeds at 12 h if pain intensity is less than 5 on the PAN-PROMISE scale. Fluid resuscitation stopped if oral intake was tolerated for more than 8 h, earliest at 20 h and 48 h after randomization in the moderate vs. aggressive groups, respectively.
Sample size
Based on an anticipated incidence of moderately severe or severe acute pancreatitis of 35%. A sample size of 744, with 372 patients in each group, for 80% power to detect a between-group difference of 10 percentage points at a two-sided significance level (alpha) of 0.05.
Two planned interim analysis after 248 and 496 patients. The study was terminated early due to safety concerns of fluid overload with the aggressive strategy.
Results
Aggressive: 122 patients; moderate: 127 patients. Baseline characteristics were well-matched.
Fluid administered during the first 48 h: Aggressive: 7.8 liters (interquartile range, 6.5 to 9.8) vs. Moderate: 5.5 liters (interquartile range, 4.0 to 6.8)
(Diagnosis of fluid overload: at least two of the following three criteria: symptoms, physical signs, and imaging evidence of hypervolemia; ARDS had to be ruled out
- Criterion 1: non-invasive evidence of heart failure (ie echo), radiographic evidence of pulmonary congestion, invasive cardiac cath suggesting heart failure.
- Criterion 2: Dyspnea
- Criterion 3: Heart failure signs: peripheral edema, pulmonary rales, increased JVP or hepatojugular reflex
Mild fluid overload: if it was responsive to medical therapy or decreased hydration and if the ratio of PaO2 to FiO2 never decreased to less than 300
Moderate fluid overload: if it was responsive to medical therapy or decreased hydration but the ratio of PaO2 to FiO2 was less than 300 at least once
Severe fluid overload: if mechanical ventilation or hemofiltration was required
Outcomes: Primary outcome, green; secondary outcomes, blue; safety outcomes, yellow
Outcome | Aggressive strategy | Moderate strategy | Significance |
Moderately severe or severe acute pancreatitis (Revised Atlanta Classification)
| 22.1% | 17.3% | NS |
Organ failure | 7.4% | 3.9% | NS |
Local complications | 20.5% | 16.5% | NS |
Persistent organ failure
| 6.6% | 1.6% | NS |
Respiratory failure | 7.4% | 2.4% | NS |
Necrotizing pancreatitis | 13.9% | 7.1% | NS |
ICU admission | 6.6% | 1.6% | NS |
Hospital LOS | 6 (4–8) d | 5 (3–7) d | NS |
PAN-PROMISE score | 23 (12–35) | 18 (10–31) | NS |
Fluid overload | 20.5% | 6.3% | RR, 2.85; 95% CI, 1.36 to 5.94) |
Fluid overload with symptoms | 18% | 7.9% | |
Fluid overload with signs | 26.2% | 11% | RR, 2.36; 95% CI, 1.33 to 4.19 |
Moderate to severe overload | 4.9% | 0.8% |
Strengths
- No loss to follow up
- Balanced baseline characteristics, except gall stone pancreatitis higher in the aggressive group
- Protocol-based fluid administration; assessment at regular time intervals at 3, 12, 24, 48, and 72 h
- Poorly reliable clinical signs were not followed in the assessment of fluid overload
- Focus on safety outcomes
Limitations
- Included only patients with mild pancreatitis
- Less co-morbidities
- Unblinded
- Sample size not achieved
- Assumed progression to moderately severe or severe pancreatitis of 35%; actual progression was only 20%
The post WATERFALL Trial – Fluid Resuscitation in Acute Pancreatitis first appeared on Critical Care Education.
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