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. 2023 Dec 14;2023(12):CD006273. doi: 10.1002/14651858.CD006273.pub4

Cerchietti 2000.

Study characteristics
Methods Randomised, comparative prospective, single‐centre trial
Method of randomisation: unclear
Blinding status: unclear
Study duration: 48 hours
Participants Prognosis ‐ terminal‐stage advanced cancer patients
≥ 1 of the following symptoms: thirst; chronic nausea or delirium; dehydration diagnosed on physical examination, with or without renal failure; and inability to maintain an adequate water intake (< 50 mL/day fluid)
Sample size: 50
Exclusions: 4 uncontrolled symptoms (pain in 2, severe dyspnoea in 2), 1 bowel obstruction syndrome requiring surgery, 3 severe constipation
Participants were recruited from Argentina.
Interventions 42 participants were randomised to 1 of 2 groups.
  • Treatment (1000 mL 5% dextrose in water infusion with the addition of 140 mEq/L sodium chloride per day, at an infusion rate of 42 mL/hour subcutaneous (20 participants)

  • Usual treatment: no subcutaneous fluids given (22 participants)

Outcomes Primary outcomes (VAS):
  • Thirst

  • Chronic nausea

  • Delirium

  • MMSE


Secondary outcomes:
  • Anguish (measurement not defined)

  • Mood (measurement not defined)

  • Interruption of hydration (oedema, increase in respiratory secretions, congestive heart failure)

  • Local adverse reactions

Identification  
Notes No conflicts of interest declared.
No grants or support reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "randomly assigned", but method not adequately described.
Comment: unclear if done
Allocation concealment (selection bias) Unclear risk Method used was not described.
Comment: unclear if done
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk No blinding described.
Comment: unclear if done
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk No blinding described.
Comment: unclear if done
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Method not described.
Comment: unclear if done
Selective reporting (reporting bias) Unclear risk Insufficient information presented.
Comment: unclear if done