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Human Albumin Protocol

Rational Use and Stewardship Guidelines
AASLD 2021 EASL 2023 AGA 2022 Surviving Sepsis 2021 ABA 2023 ASFA 2024 EMA 2022
Created By

Dr. Ahmed Khaled

Reviewed By

Dr. Mohamed Tayea • Dr. Marwa Ahmed

Executive Summary

Core Principles

Human albumin is a plasma-derived biologic with a narrow therapeutic window and high cost.

Routine correction of hypoalbuminemia or use for nutrition/wound-healing is not evidence-based.

Stewardship Principle: Reserve albumin for indications with proven clinical benefit.

Protocol Objectives

  • Standardise and rationalise albumin use across departments.
  • Eliminate non–evidence-based indications.
  • Improve patient outcomes and preserve limited supply.
  • Optimise hospital expenditure through stewardship.
  • Target >= 80% use for Primary Approved Indications (SBP, HRS, LVP).

Primary Approved Indications

SBP

Spontaneous Bacterial Peritonitis

Day 1: 1.5 g/kg IV (max 100g)
Day 3: 1 g/kg IV (max 100g)
Key Criteria:
All hospitalized SBP patients (Ascitic PMN >= 250/mm3). Start within 6h of diagnosis.
Ref: AASLD 2021 • EASL 2023

HRS-AKI

Hepatorenal Syndrome

Dx: 1 g/kg (Day 1) ± Day 2
Rx: 20–40 g/day
Key Criteria:
Combine with vasoconstrictor. Stop if no improvement after 3–5 days.
Ref: AGA 2022 • EASL 2023

LVP > 5L

Large Volume Paracentesis

Dose: 6–8 g per Litre removed
Key Criteria:
Administer during/after. 25g albumin ≈ 100mL of 25% solution.
Ref: AASLD 2021

Specialist / Limited Indications

Indication Key Criteria Dosing and Protocol Notes
Septic Shock Persistent hypotension after >= 30 mL/kg crystalloids and ongoing risk of overload. Titrate to MAP >= 65 mmHg. Stop if no benefit. Use 5% or 20%.
Burns > 20% Hypoperfusion despite >= 2 mL/kg/%TBSA crystalloids in 24h. Do not use < 12h. Start 5% albumin only after 12-24h if crystalloids fail.
TPE Therapeutic Plasma Exchange (1-1.5 plasma vol). Use 5% albumin. Use FFP if coag factors needed.
Nephrotic Edema Severe anasarca refractory to max diuretics (>=160mg furosemide). Single trial: 25-50g (25%) + Loop Diuretic. Short-term only.
Hepatic Resection Major resection > 40%, Alb < 2.0 g/dL. 5% albumin titrated cautiously. Daily reassessment.
Post-Liver Tx Persistent ascites/edema, Alb < 2.5 g/dL. 20-40 g/day, short course. Avoid routine use.

Not Recommended

  • Traumatic Brain Injury (SAFE trial: Increased mortality).
  • Routine hypoalbuminemia correction.
  • Nutritional / Wound-healing support.
  • Unselected ARDS (Restricted clause*).
  • Major trauma or haemorrhagic shock.
  • Acute pancreatitis.
  • Routine post-op use (except severe refractory edema).

*Restricted ARDS: Short trial (25% + diuretic) only in selected cases under ICU supervision with objective improvement in 24-48h.

Contraindications

ABSOLUTE Hypersensitivity to albumin/plasma proteins.
RELATIVE / CAUTION
  • Decompensated Heart Failure
  • Overt Pulmonary Edema
  • Severe Hypertension
  • Hypervolaemia
  • Anuria without fluid removal plan
💡 Note: Severe anemia is NOT a contraindication.

Prep, Admin and Monitoring

Preparation Guide

5%
Plasma Expansion
Rate: Up to 5 mL/min
20-25%
Oncotic Support
Rate: 1-2 mL/min
Dilution Formula (to make 5%):
50 mL Albumin 20% (10g) + 150 mL Normal Saline = 200 mL of 5% Albumin.

Monitoring Workflow

  • 1. Before Infusion:
    Vitals, Weight, Volume status, Electrolytes, Creatinine.
  • 2. During Infusion:
    Vitals q15-30m. Watch for dyspnea, pulmonary edema.
  • 3. After Infusion:
    Urine output, Daily weight, Creatinine, SpO2. Reassess indication.

HRS-AKI Management Module

Diagnostic Criteria and Treatment Regimen

Diagnostic Criteria

  • Cirrhosis + Ascites + AKI Criteria.
  • No Shock. No Nephrotoxic drugs.
  • Normal renal US (No CKD/Proteinuria/Hematuria).
  • No improvement after 2 days of albumin + diuretic withdrawal.

Treatment Protocol

Preferred: Terlipressin or Norepinephrine + Albumin.
Alternative: Midodrine (7.5-10mg PO q8h) + Octreotide (SC/IV) + Albumin.
STOP RULE: Max 14 days. Stop if Cr returns to baseline, no improvement in 3 days, or Pulmonary Toxicity.

Quick Decision Tree

START: Need for fluid/oncotic support?
Is it SBP / HRS-AKI / LVP > 5L?
YES
✅ Give Albumin per Protocol
NO
Septic Shock (Refractory)
or Burns > 20%?
⚠ Conditional Trial (Specialist)
❌ All Other Indications: DO NOT USE

Clinical Pearls

  • Albumin t1/2 ≈ 12–21 days.
  • Systemic inflammation lowers serum albumin by 0.5–1 g/dL.
  • 20% albumin expands plasma volume ≈ 1.7–2 × infused volume.
  • SBP: Administer within 6 h for renal protection.

Quality Indicators

Approved indication >= 95%
Correct dose >= 95%
Monitoring documented >= 95%
Specialist approval (off-label) 100%
14. Key References:
Biggins SW et al. AASLD Guidance 2021 • EASL Cirrhosis Guidelines 2023 • Evans L et al. Surviving Sepsis 2021 • ABA Fluid CPG 2023 • EMA Pharmacovigilance 2022 • ASFA/ISBT 2024 • ALBIOS Trial NEJM 2014 • Mitchell JP et al. Crit Care Med 2005.