Dialysate temperature reduction for intradialytic hypotension for people with chronic kidney disease requiring haemodialysis

Yasushi Tsujimoto; Hiraku Tsujimoto; Yukihiko Nakata; Yuki Kataoka; Miho Kimachi; Sayaka Shimizu; Tatsuyoshi Ikenoue; Shingo Fukuma; Yosuke Yamamoto; Shunichi Fukuhara

doi:10.1002/14651858.CD012598.pub2

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Figure 1

Study flow diagram

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Analysis 1.1

Comparison 1 Fixed reduction of dialysate temperature versus standard dialysate temperature, Outcome 1 Intradialytic hypotension.

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Analysis 1.2

Comparison 1 Fixed reduction of dialysate temperature versus standard dialysate temperature, Outcome 2 Discomfort rate: cold sensation, shivering, and related symptoms.

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Analysis 1.3

Comparison 1 Fixed reduction of dialysate temperature versus standard dialysate temperature, Outcome 3 Mean BP at the end of dialysis.

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Analysis 1.4

Comparison 1 Fixed reduction of dialysate temperature versus standard dialysate temperature, Outcome 4 Change in body temperature during dialysis.

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Analysis 2.1

Comparison 2 Isothermal dialysate versus thermoneutral dialysate, Outcome 1 Intradialytic hypotension.

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Analysis 2.2

Comparison 2 Isothermal dialysate versus thermoneutral dialysate, Outcome 2 Change in SBP during dialysis.

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Analysis 2.3

Comparison 2 Isothermal dialysate versus thermoneutral dialysate, Outcome 3 Change in body temperature during dialysis.

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Summary of findings for the main comparison. Fixed reduction of dialysate temperature compared to standard dialysate temperature for patients requiring haemodialysis

Fixed reduction of dialysate temperature compared to standard dialysate temperature for patients requiring haemodialysis
Patient or population: patients requiring haemodialysis Setting: dialysis centre Intervention: fixed reduction of dialysate temperature Comparison: standard dialysate temperature
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)
	Risk with standard dialysate temperature	Risk with fixed reduction of dialysate temperature
Intradialytic hypotension rate follow up: median 3 weeks	251 episodes per 1,000 person‐dialysis session	131 episodes per 1,000 person‐dialysis session (85 to 201)	RR 0.52 (0.34 to 0.80)	153 (8)	⊕⊝⊝⊝ VERY LOW ^{1 2}
Discomfort rate Follow up: median 4 weeks	25 episodes per 1,000 person‐dialysis session	208 episodes per 1,000 person‐dialysis session (47 to 928)	Rate ratio 8.31 (1.86 to 37.12)	81 (4)	⊕⊝⊝⊝ VERY LOW ^{1 2}
Dropout due to adverse events Follow up: median 3 weeks	Nine studies (268 participants) reported there were no dropouts due to adverse events		‐	268 (9)	Not graded
Death (all causes)	No studies reported the outcome		‐	‐	‐
Acute coronary syndrome	No studies reported the outcome		‐	‐	‐
Stroke	No studies reported the outcome		‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). RR: risk ratio; CI: Confidence interval
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded two levels due to serious risk of bias: all included studies were randomised cross‐over studies and carry‐over effects could be biased the result. Additionally, all studies were rated high or unclear risk of bias in at least four domains ² Downgraded one level due to serious imprecision: the total sample size included in the analysis were less than optimal information size

Summary of findings for the main comparison. Fixed reduction of dialysate temperature compared to standard dialysate temperature for patients requiring haemodialysis

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Summary of findings 2. Isothermal dialysate compared to thermoneutral dialysate in patients requiring haemodialysis

Isothermal dialysate compared to thermoneutral dialysate in patients requiring haemodialysis
Patient or population: patients requiring haemodialysis Setting: dialysis centre Intervention: isothermal dialysate Comparison: thermoneutral dialysate
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Certainty of the evidence (GRADE)
	Risk with thermoneutral dialysate	Risk with Isothermal dialysate
Intradialytic hypotension rate follow up: range 3 to 8 weeks	410 episodes per 1,000 person‐dialysis session	279 episodes per 1,000 person‐dialysis session (246 to 312)	Rate ratio 0.68 (0.60 to 0.76)	133 (2)	⊕⊝⊝⊝ Very low ^{1 2}
Discomfort rate Follow up: mean 3 weeks	One study reported that none of the patients allocated to isothermal or thermoneutral dialysate experienced shivering		‐	17 (1)	Not graded
Dropout due to adverse event follow up: range 3 to 8 weeks	There were no reported dropouts due to adverse events in the 2 studies		‐	133 (2)	Not graded
Death (all causes)	No study reported the outcome		‐	‐	‐
Acute coronary syndrome	No study reported the outcome		‐	‐	‐
Stroke	No study reported the outcome		‐	‐	‐
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect
¹ Downgraded two levels due to serious risk of bias: all included studies were randomised cross‐over studies and carry‐over effects could be biased the result. Additionally, all studies were rated high or unclear risk of bias in at least four domains ² Downgraded one level due to serious imprecision: the total sample size included in the analysis were less than optimal information size

Summary of findings 2. Isothermal dialysate compared to thermoneutral dialysate in patients requiring haemodialysis

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Comparison 1. Fixed reduction of dialysate temperature versus standard dialysate temperature

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intradialytic hypotension Show forest plot	8		Rate Ratio (Random, 95% CI)	0.52 [0.34, 0.80]

2 Discomfort rate: cold sensation, shivering, and related symptoms Show forest plot	4		Rate Ratio (Random, 95% CI)	8.31 [1.86, 37.12]

3 Mean BP at the end of dialysis Show forest plot	8	188	Mean Difference (IV, Random, 95% CI)	6.46 [2.84, 10.08]

4 Change in body temperature during dialysis Show forest plot	5	102	Mean Difference (IV, Random, 95% CI)	‐0.44 [‐0.56, ‐0.32]

Comparison 1. Fixed reduction of dialysate temperature versus standard dialysate temperature

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Comparison 2. Isothermal dialysate versus thermoneutral dialysate

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Intradialytic hypotension Show forest plot	2		Rate Ratio (Random, 95% CI)	0.68 [0.60, 0.76]

2 Change in SBP during dialysis Show forest plot	2	266	Mean Difference (IV, Random, 95% CI)	6.59 [2.44, 10.74]

3 Change in body temperature during dialysis Show forest plot	2	266	Mean Difference (IV, Random, 95% CI)	‐0.40 [‐0.60, ‐0.21]

Comparison 2. Isothermal dialysate versus thermoneutral dialysate

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