Wilkes 2001.
| Methods | Design: prospective randomized double‐blinded Withdrawals: 5 Setting: 2 centres, UK Sample size: 47 |
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| Participants | Age (mean): 71.6/73.1 years Gender (M/F): 23/24 ASA grade: average I to III Surgery type: major non‐cardiac surgery Surgery duration (mean): 3.3/3.1 hours Anaesthesia type: general |
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| Interventions |
Intervention n = 23 Buffered arm ‐ Hartmann's and 6% Hetastarch Control n = 24 Non‐buffered arm ‐ normal saline and 6% Hetastarch 500 mL of colloid at induction as a bolus followed by 7 mL/kg/h of crystalloid as an infusion according to a predefined algorithmic protocol Co‐interventions: 6% Hetastarch |
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| Outcomes | Chloride, sodium, RBCs transfused, platelets transfused, FFP transfused, urine output, base excess, pH, PaCO2, bicarbonate measured postoperatively | |
| Notes | Trial was stopped early after 1 participant experienced adverse effects that may have been caused by the study fluid. Funding source: supported in part by a grant from Abbott Laboratories and from BioTime Inc. Declarations of interest: none disclosed |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomization and stratification were instituted with the use of permuted blocks with a size of 4. |
| Allocation concealment (selection bias) | Low risk | All clinicians involved in the care of participants were blinded to group allocation. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded ‐ participants, trial conductors and assessors |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Double‐blinded ‐ participants, trial conductors and assessors |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 5 withdrawals. Study was stopped early after adverse effects possibly linked to study fluid. |
| Selective reporting (reporting bias) | Low risk | No evidence of selection bias. All proposed outcome measures adequately reported |
| Other bias | Unclear risk | Study was funded in part by BioTime Inc., which manufactures Hextend. |
ASA: American Society of Anesthesiologists; BE:base excess; CABG: coronary artery bypass graft; CI:chloride; CO2: carbon dioxide; CVP: central venous pressure; EBL: estimated blood loss; ENT: ear, nose, and throat; FFP: fresh frozen plasma; HES: hydroxyethyl starch; Hg: mercury; ICU: intensive care unit; kg: kilogram; L: litre; min: minutes; mL: millilitres; mm: millimetres; NS: normal saline; PaCO2: partial pressure of arterial carbon dioxide; PaO2: partial pressure of arterial oxygen; POD1: postoperative day 1; RBCs: red blood cells; ROTEM: Rotational Thromboelastometry (trade name); SAS: Statistical Analysis Software (trade name); SD: standard deviation; TEG: thromboelastography; VAS:visual analogue scale; vs: versus.