Evidence
This page contains a snapshot of featured content which highlights evidence addressing key clinical questions including areas of uncertainty. Please see the main topic reference list for details of all sources underpinning this topic.
BMJ Best Practice evidence tables
Evidence tables provide easily navigated layers of evidence in the context of specific clinical questions, using GRADE and a BMJ Best Practice Effectiveness rating. Follow the links at the bottom of the table, which go to the related evidence score in the main topic text, providing additional context for the clinical question. Find out more about our evidence tables.
This table is a summary of the analysis reported in a Cochrane Clinical Answer that focuses on the above important clinical question.
Confidence in the evidence is moderate or low to moderate where GRADE has been performed and there may be no difference in effectiveness between the intervention and comparison for most outcomes.
Population: People with a range of diagnoses (most commonly trauma, sepsis, septic shock, hypovolemia, haemorrhagic shock, burns) requiring fluid volume resuscitation ᵃ
Intervention: Colloids (starches; dextrans; gelatins; albumin or fresh frozen plasma) ᵇ
Comparison: Crystalloids
| Outcome | Effectiveness (BMJ rating)? | Confidence in evidence (GRADE)? |
|---|---|---|
Starch solution versus crystalloids | ||
Mortality: at the end of follow-up ᶜ | No statistically significant difference | Moderate |
Transfusion of blood product | Favours comparison | Moderate |
Renal replacement therapy | Favours comparison | Moderate |
Adverse events: allergic reaction | No statistically significant difference | Very Low |
Adverse events: itching | Occurs more commonly with starch compared with crystalloids (favours comparison) | Very Low |
Adverse events: rash | No statistically significant difference | Very Low |
Dextrans versus crystalloids | ||
Mortality: at the end of follow-up ᶜ | No statistically significant difference | Moderate |
Transfusion of blood products | No statistically significant difference | Very Low |
Adverse events: allergic reaction | No statistically significant difference | Moderate |
Renal replacement therapy | - | None of the studies identified by the review assessed this outcome |
Gelatins versus crystalloids | ||
Mortality: at the end of follow-up ᵈ | No statistically significant difference | Low |
Transfusion of blood product | No statistically significant difference | Very Low |
Adverse events | No statistically significant difference | Very Low |
Renal replacement therapy | - | See note ᵉ |
Albumin or fresh frozen plasma versus crystalloids | ||
Mortality: at the end of follow-up ᶜ | No statistically significant difference | Moderate |
Transfusion of blood product | No statistically significant difference | Very Low |
Renal replacement therapy | No statistically significant difference | Low |
Adverse events (allergic reactions) | No statistically significant difference | Very Low |
Note ᵃ Some caution may be required in interpreting the results of this Cochrane Clinical Answer (CCA) for the question of fluid resuscitation in children with sepsis due to indirectness. Of the 69 studies included in the Cochrane review underlying this CCA, seven (10.1%) recruited only children. Two studies recruited children and adults (using mean ages reported by the authors of studies with children and adults; most participants were adults over 18 years of age). Nineteen (27.5%) of the studies were exclusively in people with sepsis or sepsis shock. ᵇ Important information post-publication of the CCA: in July 2021, the US Food and Drug Administration (FDA) issued safety labelling changes for solutions containing hydroxyethyl starch (HES) stating that HES products should not be used unless adequate alternative treatment is unavailable.[106] The Pharmacovigilance Risk Assessment Committee of the European Medicines Agency in February 2022 recommended suspending HES solutions for infusion.[107] ᶜ The CCA also reports mortality within 30 days and 90 days as a subgroup analysis; moderate-quality evidence also reported no statistically significant difference between treatment groups. ᵈ Low-quality evidence also reported no statistically significant difference between gelatins and crystalloids for mortality within 30 days and 90 days. ᵉ The reviewers of the main Cochrane review which this CCA is based on found one RCT which assessed the effectiveness of colloids for this outcome, but gelatins were not reported separately.
This evidence table is related to the following section/s:
This table is a summary of the analysis reported in a guideline (underpinned by a systematic review) that focuses on the above important clinical question.
Confidence in the evidence is moderate or low to moderate where GRADE has been performed and there may be no difference in effectiveness between the intervention and comparison for key outcomes.
Population: Children with septic shock
Intervention: High-volume fluid administration ᵃ
Comparison: Low-volume fluid administration ᵃ
| Outcome | Effectiveness (BMJ rating)? | Confidence in evidence (GRADE)? |
|---|---|---|
Cumulative 72-hour survival | No statistically significant difference | Moderate |
Recommendations as stated in the source guideline The 2017 National Institute of Health and Care Excellence (NICE) guideline on the early recognition and diagnosis of sepsis makes the following recommendations: If children and young people up to 16 years need intravenous fluid resuscitation, use glucose-free crystalloids that contain sodiumᵇ, with a (low-volumeᵇ) bolus over less than 10 minutes. Take into account pre-existing conditions (for example, cardiac disease or kidney disease), as smaller fluid volumes may be needed. If neonates need intravenous fluid resuscitation, use glucose-free crystalloids that contain sodiumᵇ, with a (low-volumeᵇ) bolus over less than 10 minutes. Use a pump, or syringe if no pump is available, to deliver intravenous fluids for resuscitation to children under 12 years with suspected sepsis who need fluids in bolus form.
Note ᵃ The guideline development group only identified one study that met their inclusion criteria. This study used 20-40mL/kg lactated Ringer solution as the high volume compared with 20mL/kg lactated Ringer solution for the low volume group. ᵇ See guideline for their recommendations on intravenous fluid sodium concentration and fluid bolus dose.
This evidence table is related to the following section/s:
This table is a summary of the analysis reported in a guideline (underpinned by a systematic review) that focuses on the above important clinical question.
Confidence in the evidence is very low or low where GRADE has been performed and there may be no difference in effectiveness between the intervention and comparison for key outcomes. However, this is uncertain and new evidence could change this in the future.
Population: Neonates, infants, children, and young people (<16 years) with sepsis
Intervention: Any crystalloid or colloid fluid therapy
Comparison: Each other
| Outcome | Effectiveness (BMJ rating)? | Confidence in evidence (GRADE)? |
|---|---|---|
Gelatin versus 0.9% sodium chloride | ||
Mortality | No statistically significant difference | Low |
Haemodynamically stable at 6 hours | No statistically significant difference | Very Low |
Haemodynamically stable at 12 hours | No statistically significant difference | Low |
Dextran versus gelatin | ||
Mortality | See note ᵃ | Low |
Cardiovascular compromise (change in heart rate) (better indicated by lower values) | Favours intervention | Very Low |
Colloid versus albumin | ||
Mortality (assessed with death) | No statistically significant difference | Low |
Neurological compromise (assessed with neurological sequelae) | No statistically significant difference | Very Low |
Recommendations as stated in the source guideline The 2017 National Institute of Health and Care Excellence (NICE) guideline on the early recognition and diagnosis of sepsis makes the following recommendations: If children and young people need intravenous fluid resuscitation, use glucose-free crystalloids that contain sodiumᵇ, with a bolusᵇ over less than 10 minutes. Take into account pre-existing conditions (for example, cardiac disease or kidney disease), as smaller fluid volumes may be needed. If term neonates need intravenous fluid resuscitation, use glucose-free crystalloids that contain sodiumᵇ, with a bolusᵇ over less than 10 minutes. Re-assess term neonates, children, and young people after completion of the intravenous fluid bolus, and decide whether they need more fluids.
Note The guideline development group chose to recommend the use of isotonic crystalloids due to the lack of evidence suggesting that using an alternative fluid would be beneficial; and that while a lack of evidence precluded recommending one crystalloid over another, it was noted that 0.9% sodium chloride would be appropriate in most clinical scenarios. ᵃ Results not pooled. ᵇ See guideline for their recommendations on intravenous fluid sodium concentration and fluid bolus dose.
This evidence table is related to the following section/s:
Cochrane Clinical Answers
Cochrane Clinical Answers (CCAs) provide a readable, digestible, clinically focused entry point to rigorous research from Cochrane systematic reviews. They are designed to be actionable and to inform decision making at the point of care and have been added to relevant sections of the main Best Practice text.
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